Recall Z-0913-2022
Nextremity Solutions · initiated February 10, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
Codes / lots: Lot Number: 168125017B UDI: 00817701020059
Reason for recall
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
FDA-determined cause: Nonconforming Material/Component
Action taken
Nextremity Solutions issued Urgent Medical Device Recall letter on 2/10/22 via mail and email to Distributors and Risk Mangers. Nextremity Solutions products with the referenced part and lot number should not be used and should be quarantined and returned to Zimmer Biomet for return to Nextremity Solutions. If you have affected product at your facility, locate and quarantine affected product in your inventory. Zimmer Biomet Sales representative will remove the affected product from your facility. Complete Medical Device Recall Return Response and send to CorporateQuality.PostMarket@zimmerbiomet.com, even if you do not have affected products at your facility. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Or email to CorporateQuality.PostMarket@zimmerbiomet.com.
Details
- Recall number
- Z-0913-2022
- Initiated
- February 10, 2022
- Terminated
- October 10, 2024
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 89 units
- Distribution
- Distribution US Nationwide, Japan, and the Netherlands
- Recalling firm
- Nextremity Solutions, Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0910-2022 Class II | Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic…Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and… | 02/10/2022Terminated |
| Z-0911-2022 Class II | Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC…Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and… | 02/10/2022Terminated |
| Z-0912-2022 Class II | Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic…Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and… | 02/10/2022Terminated |
| Z-0914-2022 Class II | Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrumentProximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and… | 02/10/2022Terminated |