Nextra Hammertoe Correction System recallZ-1458-2020 · Nextremity Solutions · initiated Feb 12, 2020
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 in the affected product may be oversized in varying degrees, potentially making it difficult to connect with and remove from the proximal Nextra implant
FDA root cause category: Under Investigation by firm
What the company is doing
Nextremity notified European distributors and customers of the FSCA via a Field Safety Notice dated 2/12/2020.The Field Safety Notice instructed return of all product with the specified lot number.
Recall details
- Recall number
- Z-1458-2020
- Status
- Terminated
- Initiated by the company
- Feb 12, 2020
- Posted by the FDA
- Feb 24, 2020
- Recalling firm
- Nextremity Solutions
- Quantity
- 190 units
- Product code
- HWC
- FDA submissions
- K110445
- Distribution
- International distribution in the countries of Spain, United Kingdom, Germany, and Switzerland.
Product description
Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.
Code information (models, lots, serial numbers)
Lot Number: 168117318B UDI: 00817701020011
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-4532KMedartis Inc. · Screw, Fixation, Bone2 recalls4 reports
Product lines
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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