ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 2.0 SUTURE, REF 5100-006, 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
FDA Recall Z-0060-2012 · Posted 2011-10-18
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Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeMBI
Date Initiated2011-09-20
Date Terminated2012-07-17
Product Quantity596 units
Reason for Recall
The product is labeled with an expiration date without adequate justification.
Firm 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: [email protected]. For questions regarding this recall contact 901-867-4324.
Root Cause
Incorrect or no expiration date
Distribution Pattern
Worldwide Distribution - USA (nationwide) and countries of: Argentina, Canada, Denmark, France, Great Britain, Ireland, Japan, and Spain.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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