TriMed Hex Cortical Screw Recalled for Shorter Than Specified Length
TriMed Inc. is recalling 13 Hex Cortical Screws from the Ankle Fixation System because they are shorter than the intended design specification.
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 structural defect (shorter than specification) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
TriMed Inc. is recalling 13 units of the TriMed Hex Cortical Screw 4.0, 40 mm (REF HEX4.0-40). These non-sterile, prescription-only screws are components of the TriMed Ankle Fixation System, used in combination with various ankle bone plates to aid in fracture healing.
The recall was initiated because the bone screws are shorter than the intended design specification. The affected units are identified by Lot #170281 and UDI (01)00842188107108(11)170406(10)170281.
The affected screws were distributed in the United States to the states of Florida and Missouri. Healthcare providers and patients who may have these specific screws implanted should contact their healthcare provider or TriMed Inc. for further instructions.
The recalled product
- Product
- TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The…
- Manufacturer
- TriMed 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)
- Lot #170281
- UDI (01)00842188107108(11)170406(10)170281
Distribution
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