Zimmer Biomet, Inc.
Medical device manufacturer in Warsaw, IN.
5510(k) clearances
0PMA approvals
875recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K251834 | Persona Partial KneeHSX · Traditional | 08/15/2025SE |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersJDI · Traditional | 07/31/2025SE |
| K251620 | A.L.P.S. Proximal Humerus Plating SystemHRS · Traditional | 07/25/2025SE |
| K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter)LZO · Special | 04/18/2025SE |
| K243293 | Zimmer® Persona® Personalized Knee SystemMBH · Traditional | 12/20/2024SE |
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-0696-2021 Class II | Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter -…Device has the potential for fracture during use. | 11/20/2020Terminated |
| Z-0570-2021 Class II | Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral…Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the… | 11/17/2020Terminated |
| Z-0397-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D.…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0396-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D.…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0395-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D.…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0394-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D.…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0393-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D.…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0392-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D.…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0391-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D.…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0390-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0389-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0388-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0387-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0386-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0385-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0384-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0383-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0382-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0381-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0380-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0379-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0378-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0377-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0376-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0375-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0374-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0373-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0372-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0371-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0370-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0369-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0368-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0367-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0366-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0365-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0364-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0363-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0362-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0361-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0360-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0359-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0358-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0357-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0356-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0355-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0354-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0353-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0352-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0351-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0350-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0349-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0348-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0347-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0346-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0345-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0344-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0343-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0342-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0341-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0340-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0339-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0338-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0337-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0336-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0335-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0334-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0333-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22mm, Neutral, O.D.…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0332-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32mm, Neutral, O.D.…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0331-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0330-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0329-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0328-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0327-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0326-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0325-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0324-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0323-2021 Class II | ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral…Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm… | 09/24/2020Terminated |
| Z-0057-2021 Class II | Dual Mobility Vivacit-E Bearing, Model Number 110031009The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm. | 08/14/2020Terminated |
| Z-2234-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X40MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2233-2020 Class II | Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number 850M0055 -…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2232-2020 Class II | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2231-2020 Class II | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2230-2020 Class II | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X50MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2229-2020 Class II | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2228-2020 Class II | Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X40MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2227-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X55MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2226-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X50MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2225-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2224-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2223-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X35MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2222-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2221-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X50MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2220-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2219-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2218-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2217-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2216-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2215-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X40MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2214-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2213-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2212-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2211-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-2210-2020 Class II | Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Number…There are reports of inadequate locking of the extended tab screws. Complaints were reported where the… | 05/05/2020Terminated |
| Z-1347-2020 Class II | THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090…Potential increase in fracture rate was detected during internal testing, in addition to potential… | 01/07/2020Terminated |
| Z-0988-2020 Class II | Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed the… | 12/23/2019Terminated |
| Z-0871-2020 Class II | ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product…Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the… | 12/19/2019Terminated |
| Z-1000-2020 Class II | Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No.…The lot contained two outer pins instead of one outer and one inner pin. | 12/12/2019Terminated |
| Z-0595-2020 Class II | Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic manual surgical…Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam… | 10/25/2019Terminated |
| Z-0594-2020 Class II | Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical…Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam… | 10/25/2019Terminated |
| Z-0338-2020 Class II | cable button for NCB Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0337-2020 Class II | Cephalomedullary Nail (CMN), Various sizes, Item Nos. 47249318009 47249318010…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0336-2020 Class II | Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0335-2020 Class II | Metasul Femoral Heads, various sizes, Item Nos. 00877004001 00877004002 00877004003…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0334-2020 Class II | Metasul Taper Liner, various sizes, Item Nos. 00877000528 00877000628 00877000732…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0333-2020 Class II | FEMOROTIBIAL/FEMORAL NAIL, various sizes. Item Nos. 32855331111 32855331113 32855331115…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0332-2020 Class II | NCB-PH Plate with 4/5/7 Lock Holes, Item Nos. 0202262104 0202262105 0202262107Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0331-2020 Class II | NCB Straight Narrow Plate, various sizes, Item Nos. 0202267008 0202267010 0202267012…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0330-2020 Class II | Connection Screw for NCB Plate, Item No. 0202266002Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0329-2020 Class II | Various temporary devices used during the implantation of the device system: bone…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0328-2020 Class II | Various fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0327-2020 Class II | CABLE-READY SHORT GTR and CABLE-READY LONG GTR, Item Nos. 00223200201 00223200202Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0326-2020 Class II | Various fixation systems and accessories, Item Nos. 00118100522 00118100527 00118100530…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0325-2020 Class II | Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0324-2020 Class II | LPS-MOB ART SURF IMPL D 9MMNon-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0323-2020 Class II | Various Devices for Limb salvage arthroplasty, Item Nos. 00585000011 00585001201…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0322-2020 Class II | Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0321-2020 Class II | Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0320-2020 Class II | Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 0100551103…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0319-2020 Class II | CLS Brevius Stem Kinectiv, hip prosthesis, various sizes. Item Nos. 0100296050…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0318-2020 Class II | Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00151504636…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0317-2020 Class II | Periarticular locking plate elbow-sterile, Item Nos. 47235800503 47235800509 47235800511…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0316-2020 Class II | PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 47235800112…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0315-2020 Class II | PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 00234801304…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0314-2020 Class II | Periarticulare Plates - Elbow, Humeral and Ulna Plates, Item Nos. 00234800504…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0313-2020 Class II | PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0312-2020 Class II | Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0311-2020 Class II | SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 47235802103…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0310-2020 Class II | DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0309-2020 Class II | Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0308-2020 Class II | PERIARTICULAR PLATES - FEMUR, Item Nos. 00234700106 00234700108 00234700110 00234700112…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0307-2020 Class II | Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 00234700310…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0306-2020 Class II | TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0305-2020 Class II | ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0304-2020 Class II | NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0303-2020 Class II | NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item Nos.…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0302-2020 Class II | Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0301-2020 Class II | Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 32810503000…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0300-2020 Class II | Sidus Stem-Free Shoulder Humeral Head, Item Nos. 0104555380 0104555400 0104555420…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0299-2020 Class II | Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0298-2020 Class II | BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706…Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). | 10/10/2019Terminated |
| Z-0533-2020 Class II | BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0532-2020 Class II | LT DISC ULNA - HA/PC; RT DISC ULNA - HA/PC; LT DISC HMRL- HA/PC; RT DISC HMRL- HA/PC…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0531-2020 Class II | 2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0530-2020 Class II | BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0529-2020 Class II | GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0528-2020 Class II | HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0527-2020 Class II | Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0526-2020 Class II | Various Custom Products, Item Nos. CP102940 CP102941 CP102942 CP102943 CP102944 CP102945…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0525-2020 Class II | Comprehensive RS Cleat CAP, Item No. 110300Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0524-2020 Class II | Comprehensive HHR Tess Cleat, Item Nos. 110260 110261 110262 110263 Product Usage: N/AElevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0523-2020 Class II | Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0522-2020 Class II | HENNESSY LEFT CONST GLENOID HA, Item No. PM555360 UDI (01)00880304819597(17)260425(10)664…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0521-2020 Class II | ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0520-2020 Class II | COMP RVRS Shoulder Baseplates, including Custom Products, Item numbers 115331S 115331…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-0519-2020 Class II | Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356…Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 08/21/2019Terminated |
| Z-2537-2019 Class II | Vanguard XP Tibial Tray 87 mm Item # 195254The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2536-2019 Class II | Vanguard XP Tibial Tray 83 mm Item # 195253The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2535-2019 Class II | Vanguard XP Tibial Tray 79 mm Item # 195252The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2534-2019 Class II | Vanguard XP Tibial Tray 75 mm Item # 195251The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2533-2019 Class II | Vanguard XP Tibial Tray 73 mm Item # 195250The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2532-2019 Class II | Vanguard XP Tibial Tray 71 mm Item # 195249The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2531-2019 Class II | Vanguard XP Tibial Tray 69 mm Item # 195248The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2530-2019 Class II | Vanguard XP Tibial Tray 67 mm Item # 195247The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2529-2019 Class II | Vanguard XP Tibial Tray 65 mm Item # 195246The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2528-2019 Class II | Vanguard XP Tibial Tray 63 mm Item # 195245The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2527-2019 Class II | XP-XP Tibial Tray - Interlok 59 mm Item # 195750The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2526-2019 Class II | XP-XP Tibial Tray - Interlok 63 mm Item # 195751The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2525-2019 Class II | XP-XP Tibial Tray - Interlok 65 mm Item # 195752The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2524-2019 Class II | XP-XP Tibial Tray - Interlok 67 mm Item # 195753The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2523-2019 Class II | XP-XP Tibial Tray - Interlok 69 mm Item # 195754The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2522-2019 Class II | XP-XP Tibial Tray - Interlok 71 mm Item # 195755The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2521-2019 Class II | XP-XP Tibial Tray - Interlok 73 mm Item # 195756The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2520-2019 Class II | XP-XP Tibial Tray - Interlok 75 mm Item # 195757The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2519-2019 Class II | XP-XP Tibial Tray - Interlok 79 mm Item # 195758The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2518-2019 Class II | XP-XP Tibial Tray - Interlok 83 mm Item # 195759The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2517-2019 Class II | XP-XP Tibial Tray - Interlok 87 mm Item # 195760The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2516-2019 Class II | XP-XP Tibial Tray - Interlok 91mm Item # 195761The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2515-2019 Class II | XP-CR Tibial Tray - Porous Plasma 91 mm Item # 195291The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2514-2019 Class II | XP-CR Tibial Tray - Interlok 91 mm Item # 195279The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2513-2019 Class II | XP-CR Tibial Tray - Interlok 87 mm Item # 195278The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2512-2019 Class II | XP-CR Tibial Tray - Interlok 83 mm Item # 195277The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2511-2019 Class II | XP-CR Tibial Tray - Interlok 79 mm Item # 195276The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2510-2019 Class II | XP-CR Tibial Tray - Interlok 75mm Item # 195275The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2509-2019 Class II | XP-CR Tibial Tray - Interlok 73mm Item # 195274The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2508-2019 Class II | XP-CR Tibial Tray - Interlok 71mm Item # 195273The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2507-2019 Class II | XP-CR Tibial Tray - Interlok 69mm Item # 195272The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2506-2019 Class II | XP-CR Tibial Tray - Interlok 67mm Item # 195271The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2505-2019 Class II | XP-CR Tibial Tray - Interlok 65mm Item # 195270The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2504-2019 Class II | XP-CR Tibial Tray - Interlok 63mm Item # 195269The locking bar not fully engaging | 08/15/2019Terminated |
| Z-2503-2019 Class II | XP- CR Tibial Tray- Interlok 59mm Item # 195268The locking bar not fully engaging | 08/15/2019Terminated |