TEMA Elbow System Prostheses Recalled for Mechanical Behavior Concern
Limacorporate is recalling TEMA Elbow System prostheses due to potential differences in mechanical behavior between implanted devices and surgical revision tools. Approximately 87 devices distributed in Florida and Texas are affected.
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: This is an FDA Class II medical device recall for a total elbow prosthesis with a potential mechanical behavior concern affecting revision surgery compatibility. No injuries or illnesses have been reported, making this a risk-of-harm recall without confirmed clinical impact.
Plain-English summary
Limacorporate S.p.A. is recalling the TEMA Elbow System, a cemented total elbow prosthesis, in both Axle Small (REF 1590.15.010) and Axle Large (REF 1590.15.020) configurations.
The recall is being issued due to a potential difference in mechanical behavior between the implanted device and the tool(s) used during revision surgery. This difference could impact surgical procedures if revision becomes necessary.
Approximately 87 devices were distributed in the United States, specifically in Florida and Texas. The affected serial numbers are: Axle Small (23031752300054, 23177372300230, 23173852400087) and Axle Large (22276962300054, 23325482400047, 24006192400193).
Patients and healthcare providers with implanted devices should be aware of this mechanical behavior concern in the context of revision surgical procedures.
The recalled product
- Product
- TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.
- Manufacturer
- Limacorporate S.p.A
- Affected units
- 87
Distribution
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