Recall Z-0465-2023 ยท MDM Instrument, Manual, Surgical, General Use
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.
| Date | Dec 8, 2022 (initiated Nov 2, 2022) |
| Status | Open, Classified |
| Reason | The devices may be packaged with the wrong reamer size. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 123 pieces |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.