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U.S. Department of Health and Human Services

Class 2 Device Recall Arthrex Osteochondral Autograft Transplantation

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 Class 2 Device Recall Arthrex Osteochondral Autograft Transplantationsee related information
Date Initiated by FirmNovember 02, 2022
Date PostedDecember 08, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0465-2023
Recall Event ID 91143
Product Classification Instrument, manual, surgical, general use - Product Code MDM
ProductSmall 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
Manufacturer Reason
for Recall		The devices may be packaged with the wrong reamer size.
FDA Determined
Cause 2		Under Investigation by firm
ActionThe 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 Commerce123 pieces
DistributionDistribution 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 CycleTPLC Device Report
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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