TI ANCHOR 1.9MM W / 2-0 SUTURE, G-FORCE SUTURE ANCHOR, Tissue Anchor, REF 86TA-1920, Rx ONLY, Sterile EO, Wright, Arling
FDA device recall Z-1524-2011 · posted 2011-03-04 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- Reason for recall
- Driver may break during use.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MBI
- Quantity affected
- 10 units
- Distribution
- Nationwide Distribution including FL, NC, OH, IL, IN
- Date initiated
- 2011-01-11
- Date posted
- 2011-03-04
- Date terminated
- 2011-07-11
- Location
- Arlington, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| G-FORCE TI SUTURE ANCHOR SYSTEM (K100579) | Wrightmedicaltechnologyinc | 2010-03-26 |