Recall Z-0060-2012 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Wright Medical Technology Inc
ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 2.5mm, 2.0 SUTURE, REF 5100-006, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Product Usage: The instrument is used as a soft tissue anchor
| Date | Oct 18, 2011 (initiated Sep 20, 2011) |
| Status | Terminated |
| Reason | The product is labeled with an expiration date without adequate justification. |
| Root cause | Incorrect or no expiration date |
| Action | 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. Con |
| Quantity | 596 units |
| Distribution | Worldwide Distribution - USA (nationwide) and countries of: Argentina, Canada, Denmark, France, Great Britain, Ireland, Japan, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971282 | ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM Wrightmedicaltechnologyinc, Jun 27, 1997 |