—#104203

Product

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

FDA product code: MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K971282
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Incorrect or no expiration date

Action the firm took

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.

Recalling firm

Firm: Wright Medical Technology Inc
Address: 5677 Airline Rd, Arlington, Tennessee 38002-9501

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and countries of: Argentina, Canada, Denmark, France, Great Britain, Ireland, Japan, and Spain.

Timeline

Recall initiated: 2011-09-20
Posted by FDA: 2011-10-18
Terminated: 2012-07-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104203. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.