Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1525-2011

TI ANCHOR 2.5MM W / 2-0 SUTURE, G-FORCE (R) SUTURE ANCHOR, Tissue Anchor, REF 86TA-2520, Rx ONLY, Sterile EO...

Wright Medical Technology Inc / initiated 2011-01-11 / Terminated

Wright Medical Technology Inc began a recall of 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... on . The reason FDA records is "Driver may break during use". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1525-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Wright Medical Technology Inc
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
Product code
MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall
Driver may break during use.
FDA root cause
Other
Action
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.
Quantity in commerce
45 units
Distribution
Nationwide Distribution including FL, NC, OH, IL, IN
Product codes and lots
Lot Numbers: 060WM037095, 060WM037107, 060WM037108, 070WM037121, 070MW037122, 070WM037130, 070MW037139