Synthes 4.5 mm LCP Curved Condylar Plate Recalled for Mislabeling
Synthes USA HQ, Inc. is recalling 13 units of the 4.5 mm LCP Curved Condylar Plate because straight plates are etched with the curved plate's 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 hazard is a labeling error (mis-etching) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Synthes USA HQ, Inc. is recalling 13 units of the Synthes 4.5 mm LCP Curved Condylar Plate. This medical device is intended for buttressing multifragmentary distal femur fractures. The recall is due to a labeling error where a Straight Condylar Plate is etched with the Curved Condylar Plate part number.
The affected products are identified by Part No. 02.001.324 and lot no. 6900823. The distribution pattern includes worldwide distribution to the USA (including ID, FL, TN, NY, LA) and internationally to Canada.
Healthcare providers and consumers should stop using the affected devices and contact the recalling firm for further instructions.
The recalled product
- Product
- Synthes 4.5 mm LCP Curved Condylar Plate Intended for buttressing multifragmentary distal femur fractures.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 13
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 No. 02.001.324
- lot no. 6900823
Distribution
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