FDA Device

ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 2.0 SUTURE, REF 5100-002, 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

Hazard

The product is labeled with an expiration date without adequate justification.

What You Should Do

Remedy

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.

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Products

ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 2.0 SUTURE, REF 5100-002, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Product Usage: T
Brand
Wright Medical Technology Inc
UPC
Lot Numbers: 01816080116, 02916090218, 03716070304, 03816080307, 03916090316, 04016100426, 04116110421, 05016100513, 05916090502, 06516050616, 06616060627, 06916090617, 07716070725, 07816080721, 09016100923, 09816080905, 09916090905, 10916091012, 11516051115, 11516051122, 11616061107, 12516051207, 12916091221

Units Affected

1099 units

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