Arthrex Small Joint OATS Sets recalled for incorrect reamer size packaging
Arthrex Small Joint OATS Sets may contain the wrong size cannulated reamer. Surgeons should verify instrument sizes before use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a risk-of-harm condition—surgical instruments may not match their labeled designation, creating potential for surgical complications. No injuries or adverse events have been reported, placing this at the High (3) severity level per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Arthrex, Inc. is recalling Small Joint OATS Sets, reference numbers AR-8981-06S (6mm) and AR-8981-08S (8mm). These are sterile surgical instrument sets used in orthopedic joint procedures. The devices may be packaged with the wrong size cannulated reamer.
Affected units total 123 pieces, distributed to medical facilities in the following U.S. states: AL, AR, CA, CO, FL, IA, IL, LA, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TX, UT, and VA. International distribution included Ecuador, Germany, Russia, Canada, China, Finland, France, Germany, Portugal, and the United Kingdom. No military or government facilities received affected devices.
A mismatch between the instrument set designation and the actual reamer size included poses a risk of operational error during surgery. No injuries or adverse events have been reported to date.
The recalled product
- Product
- 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.
- Manufacturer
- Arthrex, Inc.
- Affected units
- 123
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- AR-8981-06S
- batch 2003118198
- UDI/DI 00888867056817
- and AR-8981-08S
- batch 2014118685
- UDI/DI 00888867056824.
Distribution
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