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U.S. Department of Health and Human Services

Class 2 Device Recall ANCHORLOK

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  Class 2 Device Recall ANCHORLOK see related information
Date Initiated by Firm September 20, 2011
Date Posted October 18, 2011
Recall Status1 Terminated 3 on July 17, 2012
Recall Number Z-0064-2012
Recall Event ID 59998
510(K)Number K971282  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 3.5mm, 2 SUTURE, REF 5100-0014, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002


Product Usage: The instrument is used as a soft tissue anchor
Code Information Lot Numbers: 01516050108, 02916090204, 02916090209, 03016100308, 03716070319, 03916090306, 03916090313, 04116110428, 04416040428, 04516050419, 04916090403, 05116110513, 05516050505, 05516050517, 06016100604, 06416040622, 06616060607, 06616060630, 06716070601, 06716070622, 06916090626, 07416040723, 07616060721, 07816080702, 07816080702, 07816080710, 08016100728, 08016100820, 08416040828, 08616060801, 08716070808, 08816080805, 08916080906, 09916090902, 10716071002, 10816081030, 10916091013, 11316031114, 11616061112, 11716071104, 12316031210, 12816081204, 12916091228
Recalling Firm/
Manufacturer		 Wright Medical Technology Inc
5677 Airline Rd
Arlington TN 38002-9501
For Additional Information Contact Cathy A.M. Park
901-867-4324
Manufacturer Reason
for Recall		 The product is labeled with an expiration date without adequate justification.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action The firm, Wright Medical Technology, Inc., sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated September 20, 2011 to all affected consignees. The letters identified the products, the problem, and the actions to be taken. The letter instructed consignees to identify affected inventory. If recalled products are located consignees are instructed to contact customer service at 1-800-238-7117, for specific instructions on how to return the recalled products. The letter asked that this communication be forward to any associated sites if the recalled products were further distributed. Consignees are to complete and return the enclosed notification form by fax to 901-867-7401 or by email to: cathy.park@wmt.com. For questions regarding this recall contact 901-867-4324.
Quantity in Commerce 4472 units
Distribution Worldwide Distribution - USA (nationwide) and countries of: Argentina, Canada, Denmark, France, Great Britain, Ireland, Japan, and Spain.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MBI and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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