Nextra Hammertoe Correction System recallZ-0913-2022 · Nextremity Solutions · initiated Feb 10, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nextremity Solutions or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected], 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 [email protected].
Recall details
- Recall number
- Z-0913-2022
- Status
- Terminated
- Initiated by the company
- Feb 10, 2022
- Recalling firm
- Nextremity Solutions
- Quantity
- 89 units
- Product code
- HWC
- FDA submissions
- K110445
- Distribution
- Distribution US Nationwide, Japan, and the Netherlands
Product description
Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
Code information (models, lots, serial numbers)
Lot Number: 168125017B UDI: 00817701020059
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Nextra Hammertoe Correction System NX-3532K-SCMedartis Inc. · Screw, Fixation, Bone1 recall5 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 89764).
- Z-0910-2022 · TerminatedNextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
- Z-0911-2022 · TerminatedNextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument
- Z-0912-2022 · TerminatedNextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument
- Z-0914-2022 · TerminatedNextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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