Z-1524-2011
TI ANCHOR 1.9MM W / 2-0 SUTURE, G-FORCE SUTURE ANCHOR, Tissue Anchor, REF 86TA-1920, Rx ONLY, Sterile EO...
Wright Medical Technology Inc / initiated 2011-01-11 / Terminated
Wright Medical Technology Inc began a recall of TI ANCHOR 1.9MM W / 2-0 SUTURE, G-FORCE SUTURE ANCHOR, Tissue Anchor, REF 86TA-1920, 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-1524-2011
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Wright Medical Technology Inc
- Product
- TI ANCHOR 1.9MM W / 2-0 SUTURE, G-FORCE SUTURE ANCHOR, Tissue Anchor, REF 86TA-1920, 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
- 10 units
- Distribution
- Nationwide Distribution including FL, NC, OH, IL, IN
- Product codes and lots
- Lot Numbers: 060WM037106, 060WM37118, 060WM37119, 070WM037147
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
