Recall Z-1524-2011 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Wright Medical Technology Inc
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
| Date | Mar 4, 2011 (initiated Jan 11, 2011) |
| Status | Terminated |
| Reason | Driver may break during use. |
| 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 | 10 units |
| Distribution | Nationwide Distribution including FL, NC, OH, IL, IN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100579 | G-FORCE TI SUTURE ANCHOR SYSTEM Wrightmedicaltechnologyinc, Mar 26, 2010 |