| Class 2 Device Recall ANCHORLOK |  |
Date Initiated by Firm | September 20, 2011 |
Date Posted | October 18, 2011 |
Recall Status1 |
Terminated 3 on July 17, 2012 |
Recall Number | Z-0059-2012 |
Recall Event ID |
59998 |
510(K)Number | K971282 |
Product Classification |
Fastener, fixation, nondegradable, soft tissue - Product Code MBI
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Product | ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 0 SUTURE, REF 5100-004,1 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: 02516050128, 03716070302, 04416040414, 06516050617, 06916090607, 07516050707, 09716070913, 09916090901, 10316031020, 10516051017, 10616061016, 10616061020, 10916091006, 11516051107, 11616061030, 11616061103, 12316031213, 12316031216, 12716071219, 12916091222 |
Recalling Firm/ Manufacturer |
Wright Medical Technology Inc 5677 Airline Rd Arlington TN 38002-9501
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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 | 1228 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 |
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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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MBI
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