Arthrex, Inc.: 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.

Hazard

The devices may be packaged with the wrong reamer size.

Details from the source

Reason for recall: The devices may be packaged with the wrong reamer size. Distribution: Distribution was made to AL, AR, CA, CO, FL, IA, IL, LA, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TX, UT, and VA. There was no military/government distribution. Foreign distribution was made to Ecuador, Germany, Russia, Canada, China, Finland, France, Germany, Portugal, and the United Kingdom. Quantity: 123 pieces Lot/code info: AR-8981-06S, batch 2003118198, UDI/DI 00888867056817; and AR-8981-08S, batch 2014118685, UDI/DI 00888867056824.

UPC codes

00888867056817, 00888867056824

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.