Synthes Humerus Plates Recalled for Incorrect Part Number Labeling
Synthes (USA) Products LLC is recalling 36 units of VA-LCP Humerus Plates because one part number was incorrectly etched on the device.
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 involves a minor labeling error (incorrect part number etching) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Synthes (USA) Products LLC is recalling 36 units of Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates and Extended Medial Distal Humerus Plates. The recall was initiated because the devices were found to be labeled incorrectly. Specifically, part number 02.117.410S was incorrectly etched with part number 02.117.610S.
The affected products are sterile orthopedic plates intended for the fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) with fused growth plates. The recall covers specific lot numbers 8009075 and 8007085.
The products were distributed in the United States to the states of Ohio, Illinois, Pennsylvania, West Virginia, Florida, Arizona, California, Alabama, North Dakota, Kentucky, Minnesota, New Jersey, Michigan, Georgia, Indiana, Tennessee, Virginia, North Carolina, and Louisiana. Healthcare providers and facilities should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile and Synthes 2.7MM/3.5MM VA-LCP Extended Medial Distal Humerus Plates 10H/RT/189mm-Sterile The Synthes 2.7 mm/3.5 mm Variable Angle LCP Elbow System is intended for fixation of fractures of the…
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 36
Distribution
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