Device 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.
Z-1800-2015
Product summary
- Firm
- Synthes, Inc.
- Event
- Event 71276
- Status
- Terminated
- Classification
- Class II
- Quantity
- 54
- Official record key
device-enforcement:Z-1800-2015
Official wording
Reason: Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.
Code information: Part Numbers: 02.240.044, 02.240.244, Lot Numbers 8886011, 8886046
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly.