TriMed Recalls Semi-Tubular Plates Due to Screw Failure During Implantation
Trimed Inc is recalling 30 units of SMTP-10 Semi-Tubular Plates because a non-locking screw passed through a plate hole during implantation.
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 mechanical failure during implantation, representing a risk-of-harm product where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Trimed Inc is recalling 30 units of the TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10. The recall was initiated because a non-locking screw passed through a hole in a plate during an implantation procedure.
The affected plates are made of surgical steel and are intended for the fixation of long bone fractures in the tibia, fibula, ulna, radius, and humerus. The specific lot number is 06206.
The product was distributed nationwide in the United States, including in Alabama, Florida, Indiana, Connecticut, California, Wisconsin, Missouri, and Hawaii, as well as in Sweden and South Africa. The source text does not specify instructions for consumers or healthcare providers regarding the handling of the recalled units.
The recalled product
- Product
- TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conformance with ASTM F138 or F139. The plate is used to fixation of long bone…
- Manufacturer
- Trimed Inc
- Affected units
- 30
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 (1)
- Lot no. 06206
Distribution
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