Synthes Recalls Six LCP Dia-Meta Volar Distal Radius Plates Due to Packaging Error
Synthes (USA) Products LLC is recalling six LCP Dia-Meta Volar Distal Radius Plates because the preprinted outer boxes were incorrect, though the internal product labels are accurate.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a packaging-only problem where the internal product labels are correct, and no adverse health consequences or injuries have been reported.
Plain-English summary
Synthes (USA) Products LLC is recalling six units of the LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile. The product is indicated for fractures, osteotomies, and non-unions of the radius and other small bones. The recall is limited to Lot Number 9890811 and Catalog ID 02.110.115S.
The recall was initiated because the product was incorrectly packaged. While the labels on the outside of the box and on the plate inside are correct, the preprinted box itself is incorrect. The box is preprinted for a 4.5 mm LCP Condylar Plate - Distal Femur, which is a different device than the one contained inside.
The affected units were distributed to one customer in Colorado. No illnesses or injuries have been reported in connection with this recall. Healthcare providers and customers should stop using the affected units and contact Synthes (USA) Products LLC for instructions on how to return the product.
The recalled product
- Product
- LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones.
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 6
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)
- Lot Number 9890811
- Catalog ID 02.110.115S
Distribution
Distributed in 1 state:
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