Recall Z-0819-2011
DePuy Spine, Inc. · initiated October 2, 2010
Product
Depuy Spine Mountaineer OCT Spinal System Screw Caddy, Non Sterile Product Code: 2883-90-420 The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior to use in surgery. Further, the caddy provides a means to organize the screws in accordance with the length of the screws.
Codes / lots: Not lot coded
Reason for recall
The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy
FDA-determined cause: Labeling design
Action taken
Depuy Spine issued an "URGENT-VOLUNTARY PRODUCT RECALL NOTIFICATION" via e-mail on October 2, 2010 to customers. The notification describes the product, problem and action to be taken by customers. The customers were instructed to please distribute this information to appropriate personnel at their facility and return any caddies that they may have to their local distributor for DePuy Spine products. Depuy will return devices to customer promptly (within two business days), after reworking the devices by removing the scale altogether. Once the product is fully corrected, Depuy will provide the customers with a new and updated unit with the corrected scale markings. If you should have any questions or concerns regarding this action, please contact DePuy Spine Customers Service at 800-227-6633.
Details
- Recall number
- Z-0819-2011
- Initiated
- October 2, 2010
- Posted by FDA
- December 27, 2010
- Terminated
- April 15, 2011
- Product code
- LRP – Tray, Surgical
- Quantity
- 237 units
- Distribution
- Nationwide distribution: USA including states of: AR, AZ, CA, FL, HI, IA, IL, KY, LA, MA, MI, MN, MO, NC, NY OH, PA, TN, TX, VA, and WA.
- Recalling firm
- DePuy Spine, Inc., Raynham, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0817-2011 | Depuy Spine Mountaineer OCT Caddy Set, Non-Sterile Product Code: 2883-90-000 The…The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw… | 10/02/2010Terminated |
| Z-0818-2011 | Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set, , Non Sterile Product Code:…The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw… | 10/02/2010Terminated |