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.
This recall has been terminated (originally issued June 15, 2015).
- Company
- Synthes, Inc.
- Recall Initiated
- May 13, 2015
- Posted
- June 15, 2015
- Terminated
- August 18, 2016
- Recall Number
- Z-1800-2015
- Quantity
- 54
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.
Distribution
Nationwide Distribution
Lot / Code Info
Part Numbers: 02.240.044, 02.240.244, Lot Numbers 8886011, 8886046
Root Cause
Employee error
Action Taken
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.