Reported Mar 18, 2020 · Terminated
Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra…
Nextremity Solutions
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nextremity Solutions · 6210 N Buffalo St · Warsaw, IN · 46580
Is this the product you have?
- Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile
- REFNX-4532K -
- Product UsageThe 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
- Lot codes and dates
- Lot Number168117318B
- UDI00817701020011
- Amount recalled
- 190 units
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
This product could cause temporary or reversible health problems — stop using it.
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