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
- Recall Number
- Z-0465-2023
- Event Number
- 91143
- Firm
- Arthrex, Inc.
- FEI Number
- 1220246
- Product Code
- MDM
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- November 2, 2022
- Posted
- December 8, 2022
- Address
- 1370 Creekside Blvd, Naples, FL, 34108-1945
Description
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.
The devices may be packaged with the wrong reamer size.
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.
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.
123 pieces