| Class 2 Device Recall Arthrex Osteochondral Autograft Transplantation |  |
Date Initiated by Firm | November 02, 2022 |
Date Posted | December 08, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0465-2023 |
Recall Event ID |
91143 |
Product Classification |
Instrument, manual, surgical, general use - Product Code MDM
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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. |
Code Information |
AR-8981-06S, batch 2003118198, UDI/DI 00888867056817; and AR-8981-08S, batch 2014118685, UDI/DI 00888867056824. |
Recalling Firm/ Manufacturer |
Arthrex, Inc. 1370 Creekside Blvd Naples FL 34108-1945
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Manufacturer Reason for Recall | The devices may be packaged with the wrong reamer size. |
FDA Determined Cause 2 | 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 in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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