Recall Z-1816-2016
Biomet, Inc. · initiated April 1, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories
Codes / lots: Part #'s 900360 900364 900360H 900360HI 900363H 900364I Lot #'s 606770 343280 420090 742780 763750 742780 565910 343280
Reason for recall
Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
FDA-determined cause: Equipment maintenance
Action taken
Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 1, 2016, to all affected customers. Customers were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Details
- Recall number
- Z-1816-2016
- Initiated
- April 1, 2016
- Posted by FDA
- May 26, 2016
- Terminated
- May 23, 2017
- Product code
- GEA – Cannula, Surgical, General & Plastic Surgery
- Distribution
- Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.
- Recalling firm
- Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1815-2016 Class II | Various trauma and sports medicine instruments and implants. guide, surgical, instrumentInsufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1817-2016 Class II | Various trauma and sports medicine instruments and implants. Plate, fixation, bone.Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1818-2016 Class II | Various trauma and sports medicine instruments and implants. Arthroscope.Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1819-2016 Class II | Various trauma and sports medicine instruments and implants. Rod, fixation…Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1820-2016 Class II | Various trauma and sports medicine instruments and implants. Reamer.Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1821-2016 Class II | Various trauma and sports medicine instruments and implants. Bit, drill.Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1822-2016 Class II | Various trauma and sports medicine instruments and implants. Pin, fixation, smooth.Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1823-2016 Class II | Various trauma and sports medicine instruments and implants. Screw, fixation, bone.Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1824-2016 Class II | Various trauma and sports medicine instruments and implants. Passer.Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1825-2016 Class II | Various trauma and sports medicine instruments and implants. Appliance, fixation…Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1826-2016 Class II | Various trauma and sports medicine instruments and implants. Spinal interlaminal…Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1827-2016 Class II | Various trauma and sports medicine instruments and implants. Orthopedic manual surgical…Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |
| Z-1828-2016 Class II | Various trauma and sports medicine instruments and implants. Fastener, fixation…Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile… | 04/01/2016Terminated |