Recall Z-1800-2015 ยท HWC Screw, Fixation, Bone
Synthes, Inc.
3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic bone.
| Date | Jun 15, 2015 (initiated May 13, 2015) |
| Status | Terminated |
| Reason | Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly. |
| Root cause | Employee error |
| Action | DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated May 13, 2015, to all affected customers to advise them about the issue and associated risks. These accounts were asked to review inventory, immediately remove the affected lots that are still in the original packaging from stock, and to complete and return the response and return authorization forms. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes consultant. |
| Quantity | 54 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |