Recall Z-0536-2010 ยท LRK Device, Anti-Snoring
Medtronic Xomed, Inc.
Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450200. Distributed by Medtronic Xomed, Inc., Jacksonville, Florida 32216 U.S.A.
| Date | Dec 15, 2009 (initiated Jul 27, 2009) |
| Status | Terminated |
| Reason | Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was inadvertently placed on the Repose Screw and vice versa. |
| Root cause | Labeling mix-ups |
| Action | Firm notified customers by phone on 7/27/2009. Firm asked customers to check inventories for the affected products listed on the enclosed Checklist. 1. Fill-in the "quantity on-hand "column on the checklist. 2. If you have any this product lot, contact Medtronic ENT Customer Service at 800-874-5797 (select Option 1 for Customer Service) and ask for the REPOSE Field Action Contact Person for help to arrange for returns and replacements or credit. 3. Fax your Checklist to Medtronic ENT at the number provided. 4. Return products clearly marked. |
| Quantity | 13 |
| Distribution | 9 consignees in the continental United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981677 | REPOSE BONE SCREW SYSTEM Influence, Inc., Aug 27, 1999 |