Reported Oct 2, 2013 · Terminated
Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of…
Synthes USA HQ, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes USA HQ, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- 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.
- Lot codes and dates
Part Number 241.267lot number 8037923
- Amount recalled
- 2
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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