—#97587

Product

TI ANCHOR 2.5MM W / 2-0 SUTURE, G-FORCE (R) SUTURE ANCHOR, Tissue Anchor, REF 86TA-2520, Rx ONLY, Sterile EO, Wright, Arlington, TN USA Used in the repair of tendons and ligaments

FDA product code: MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K100579
Affected lot / code info: Lot Numbers: 060WM037095, 060WM037107, 060WM037108, 070WM037121, 070MW037122, 070WM037130, 070MW037139

Why it was recalled

Driver may break during use.

Root cause (FDA determination)

Other

Action the firm took

Wright Medical Technology Inc initiated their recall of the product by telephone to their distributors on January 11, 2011. The firm followed with letters sent on February 1, 2011, to distributors, hospital administrators, and surgeons. Distributors were asked to immediately complete the attached response form, confirming receipt of the notice, and return a copy to Wright Medical by fax to 901-867-4788. For questions they were instructed to call 800-874-5630. For questions regarding this recall call 901-867-4788.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution including FL, NC, OH, IL, IN

Timeline

Recall initiated: 2011-01-11
Posted by FDA: 2011-03-04
Terminated: 2011-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97587. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.