Synthes 3.5 MM LCP Distal Humerus System Recalled for Mislabeled Part Numbers
Synthes USA HQ, Inc. is recalling two units of the 3.5 MM LCP Distal Humerus System because the part was mislabeled with an incorrect part number.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies the issue as a labeling error without reporting any illnesses or injuries, which aligns with the Moderate severity criteria for minor labeling errors.
Plain-English summary
Synthes USA HQ, Inc. is recalling two units of the Synthes 3.5 MM LCP Distal Humerus System. The recall is being initiated because the product was mislabeled; specifically, Part Number 241.267 was mislabeled with Part Number 241.276.
The affected product is intended for the fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. The recall involves lot number 8037923. The product was distributed nationwide, including California and Virginia.
Healthcare providers and patients should verify the part numbers on their devices. If the device matches the recalled part number and lot number, it should be removed from service and returned to the manufacturer or distributor for further instructions.
The recalled product
- 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…
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part Number 241.267
- lot number 8037923
Distribution
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