TEMA Axle Small elbow prosthesis recalled due to unapproved component
Limacorporate recalled 5 TEMA Axle Small elbow prostheses due to inclusion of a component not cleared for U.S. marketing. Affected systems were distributed to Texas.
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 a Class II FDA recall involving a medical device containing an unapproved component. As a risk-of-harm product without documented incidents in the recall notice, it meets the High severity criterion.
Plain-English summary
Limacorporate S.p.A is recalling the TEMA Axle Small elbow prosthesis (Product Code 1590.15.010, Lot Number 2115522). Five units of this orthopedic medical device were affected by the recall.
The recall was issued because an incorrect component that has not been cleared for marketing in the United States was included in the elbow prosthesis. This component does not meet U.S. regulatory requirements.
The recalled devices were distributed to healthcare facilities in Texas.
The recalled product
- Product
- TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
- Manufacturer
- Limacorporate S.p.A
- Category
- Medical Device — Orthopedic
- Hazard
- Affected units
- 5
Distribution
Distributed in 1 state:
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