Synthes 2.4 mm LC-DCP Plate Recalled Due to Foreign Object
Synthes (USA) Products LLC is recalling 13 units of 2.4 mm LC-DCP Plates because a screw was found in a package labeled for the plate.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (foreign object contamination) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Synthes (USA) Products LLC is recalling 13 units of the Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm. The product is intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.
The recall was initiated after a complaint was reported regarding a screw being found in a package labeled for the 2.4 mm LC-DCP Plate. The affected units are identified by Part No. 249.926 and lot No. 8093100.
The products were distributed nationwide in the United States, including in Indiana, New York, Washington, Nebraska, Maryland, Texas, Alabama, and Michigan, as well as internationally to Canada. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected plates.
The recalled product
- Product
- Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.
- Manufacturer
- Synthes (USA) Products LLC
- 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. 249.926
- lot No. 8093100
Distribution
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