Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450200. Distributed by Medtronic Xomed, Inc., Jacksonville, Florida
FDA device recall Z-0536-2010 · posted 2009-12-15 · Terminated
Recall details
- Recalling firm
- Medtronic Xomed, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- LRK
- Quantity affected
- 13
- Distribution
- 9 consignees in the continental United States.
- Date initiated
- 2009-07-27
- Date posted
- 2009-12-15
- Date terminated
- 2010-03-15
- Location
- Jacksonville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REPOSE BONE SCREW SYSTEM (K981677) | Influence, Inc. | 1999-08-27 |