Synthes 2.4 mm VA-LCP Distal Radius Plate Recall for Mislabeling
Synthes USA HQ, Inc. is recalling 11 units of 2.4 mm VA-LCP distal radius plates that may be incorrectly etched with 'R' instead of 'L'.
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 a moderate severity score.
Plain-English summary
Synthes USA HQ, Inc. is recalling 11 units of the Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right. The recall involves Part No. 02.111.730 with Lot No. 3614792. These medical devices are intended for the fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
The recall was initiated because there is a possibility that the plates from this specific lot are etched with "R" for right when they should be etched with "L" for left. This labeling error could result in the implantation of a plate intended for the wrong side of the body.
The affected units were distributed nationwide in the United States, specifically in the states of Florida, Georgia, North Carolina, Ohio, Kentucky, New Jersey, Idaho, Indiana, and Minnesota. Healthcare providers and patients should verify the lot number and side designation of any implanted or pending implants to ensure they match the intended surgical site.
The recalled product
- Product
- Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 11
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. 02.111.730
- with Lot No. 3614792
Distribution
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