Z-1261-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2023
- Initiation Date
- January 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 systems
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.
Distribution Pattern
U.S. Distribution to: TX
Code Information
Product Code: 1590.15.010 UDI-DI Code: 08033390128865 Lot Number: 2115522 Sterilization Lot Number: 2100241