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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Arthrex, Inc.
Lot Codes / Batch Numbers
AR-8981-06S, batch 2003118198, UDI/DI 00888867056817, and AR-8981-08S, batch 2014118685, UDI/DI 00888867056824.
Products Sold
AR-8981-06S, batch 2003118198, UDI/DI 00888867056817; and AR-8981-08S, batch 2014118685, UDI/DI 00888867056824.
Arthrex, Inc. is recalling Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both con due to The devices may be packaged with the wrong reamer size.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The devices may be packaged with the wrong reamer size.
Recommended Action
Per FDA guidance
The recall notifications were initiated on 11/2/2022 via email. They described the product affected, reason for recall, and provided required actions for the different U.S. and OUS consignees. The U.S. distributor consignees were instructed to contact Field Logistics Services to arrange for return of the affected product. The direct customers (medical facilities) were to contact Arthrex Product Surveillance then they will be further instructed. No response forms were included.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AR, CA, CO, FL, IL, IA, LA, MD, MA, MI, NJ, NY, NC, OH, PA, SC, TX, UT, VA
Page updated: Jan 10, 2026