Reported Apr 20, 2022 · Terminated
Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument
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 · 1195 Polk Dr · Warsaw, IN · 46582-8602
Is this the product you have?
- Nextra Hammertoe Correction System 4.5 Middle and 3.2
- Proximal Saw Cut SKUNX-4532K-SC Orthopedic surgical instrument
- Lot codes and dates
- Lot Number
168117318C168125017D
- UDI00817701020004
- Lot Number
- Amount recalled
- 459 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
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
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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