Recall Z-1800-2015
Synthes, Inc. · initiated May 13, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Part Numbers: 02.240.044, 02.240.244, Lot Numbers 8886011, 8886046
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.
FDA-determined 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.
Details
- Recall number
- Z-1800-2015
- Initiated
- May 13, 2015
- Posted by FDA
- June 15, 2015
- Terminated
- August 18, 2016
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 54
- Distribution
- Nationwide Distribution
- Recalling firm
- Synthes, Inc., West Chester, PA