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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Nextremity Solutions: During insertion of the middle phalanx implant into bone, the driver may deform the implant locking mechanism and result in inadequate mating force between the middle and proximal phalanx implants, resulting in surgical delay, in-situ removal of the implant, use of alternative surgical approach, disassembly of the implants post-operatively, and revision

Agency Publication Date: March 9, 2022
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Affected Products

Product: Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT

Lot Number: 1578401 UDI: 00817701026389

Lot Numbers:
Number
Product: Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT

Lot Numbers: 1574701, 158961 UDI: 00817701026372

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89588
Status: Resolved
Manufacturer: Nextremity Solutions
Manufactured In: United States
Units Affected: 2 products (23 units; 24 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.