Reported Dec 14, 2022 · Ongoing
Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a…
Arthrex, Inc.
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: Arthrex, Inc. · 1370 Creekside Blvd · Naples, FL · 34108-1945
Is this the product you have?
- Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.
- Lot codes and dates
AR-8981-06Sbatch 2003118198UDI/DI 00888867056817and AR-8981-08Sbatch 2014118685UDI/DI 00888867056824
- Amount recalled
- 123 pieces
Where it was sold
Why it was recalled
The devices may be packaged with the wrong reamer size.
This product could cause temporary or reversible health problems — stop using it.
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