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.
Reported: January 1, 2025 Initiated: October 2, 2024 #Z-0744-2025
Product Description
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.
Reason for Recall
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
Details
- Recalling Firm
- Limacorporate S.p.A
- Units Affected
- ~87 devices (U.S.)
- Distribution
- U.S: FL and TX O.U.S.: N/A
- Location
- San Daniele Del Friuli
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Limacorporate S.p.A. Units affected: ~87 devices (U.S.).
Why was this product recalled? ▼
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2025. Severity: Moderate. Recall number: Z-0744-2025.
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