TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Reported: March 22, 2023 Initiated: January 25, 2023 #Z-1261-2023
Product Description
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Reason for Recall
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
Details
- Recalling Firm
- Limacorporate S.p.A
- Units Affected
- 5 systems
- Distribution
- U.S. Distribution to: TX
- Location
- San Daniele Del Friuli, N/A
Frequently Asked Questions
What product was recalled? ▼
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling). Recalled by Limacorporate S.p.A. Units affected: 5 systems.
Why was this product recalled? ▼
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 22, 2023. Severity: Moderate. Recall number: Z-1261-2023.
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