Recall Z-0818-2011 ยท LRP Tray, Surgical
DePuy Spine, Inc.
Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set, , Non Sterile Product Code: 2883-90-400 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.
| Date | Dec 27, 2010 (initiated Oct 2, 2010) |
| Status | Terminated |
| Reason | The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy |
| Root cause | Labeling design |
| Action | 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 |
| Quantity | 121 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.