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U.S. Department of Health and Human Services

Class 2 Device Recall Arthrex SwiveLock Anchor

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  Class 2 Device Recall Arthrex SwiveLock Anchor see related information
Date Initiated by Firm June 14, 2021
Create Date July 21, 2021
Recall Status1 Open3, Classified
Recall Number Z-2107-2021
Recall Event ID 88200
510(K)Number K203495  
Product Classification Fastener, fixation, biodegradable, soft tissue - Product Code MAI
Product Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Code Information Lots 12758314 and 13022357
Recalling Firm/
Manufacturer		 Arthrex, Inc.
1370 Creekside Blvd
Naples FL 34108-1945
For Additional Information Contact Arthrex Product Surveillance
866-267-9138
Manufacturer Reason
for Recall		 Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
FDA Determined
Cause 2		 Under Investigation by firm
Action On June 14, 2021 the firm e-mail their consignees with the following instructions: Immediately discontinue use, sale, and distribution of the affected lots of product. and to contact the Field Logistics Services at FLS@arthrex.com to answer questions regarding credit for affected devices in your possession.
Quantity in Commerce 3985 pieces
Distribution US Nationwide Distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Hawaii.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = MAI and Original Applicant = Arthrex Inc.
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