ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 2 SUTURE, REF 5100-0010, 1 each, STERILE R, Wright Medica
FDA device recall Z-0062-2012 · posted 2011-10-18 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- Reason for recall
- The product is labeled with an expiration date without adequate justification.
- Action taken
- The firm, Wright Medical Technology, Inc., sent an "URGENT: PRODUCT RECALL NOTIFICATION" letter dated September 20, 2011 to all affected consignees. The letters identified the products, the problem, and the actions to be taken. The letter instructed consignees to identify affected inventory. If recalled products are located consignees are instructed to contact customer service at 1-800-238-7117, for specific instructions on how to return the recalled products. The letter asked that this communication be forward to any associated sites if the recalled products were further distributed. Consignees are to complete and return the enclosed notification form by fax to 901-867-7401 or by email to: cathy.park@wmt.com. For questions regarding this recall contact 901-867-4324.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- MBI
- Quantity affected
- 1237 units
- Distribution
- Worldwide Distribution - USA (nationwide) and countries of: Argentina, Canada, Denmark, France, Great Britain, Ireland, Japan, and Spain.
- Date initiated
- 2011-09-20
- Date posted
- 2011-10-18
- Date terminated
- 2012-07-17
- 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 |
|---|---|---|
| ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM (K971282) | Wrightmedicaltechnologyinc | 1997-06-27 |