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Synthes USA HQ, Inc. recalls Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of
Recalled October 2, 2013 · FDA recall Z-2278-2013 · Synthes USA HQ
Hazard
Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276). · FDA Class II
Units
2
Sold at
Nationwide Distribution including CA,and VA. .
Description
Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).
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.
Manufacturer(s)
Synthes USA HQ, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →