Device product
Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.
Z-2278-2013
Product summary
- Event
- Event 65009
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-2278-2013
Official wording
Reason: Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).
Code information: Part Number 241.267, lot number 8037923
Distribution pattern: Nationwide Distribution including CA,and VA. .
Derived failure modes
-
Labeling or packaging
mislabeled