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.
- Recall Initiated
- October 2, 2024
- Posted
- December 20, 2024
- Recall Number
- Z-0744-2025
- Quantity
- ~87 devices (U.S.)
Reason for Recall
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
Distribution
U.S: FL and TX O.U.S.: N/A
Lot / Code Info
Product/Catalog Numbers: 1590.15.010 TEMA ELBOW - AXLE SMALL UDI-DI code: 08033390128865 Lot/Serial Numbers: 23031752300054 23177372300230 23173852400087 Product/Catalog Number: 1590.15.020 TEMA ELBOW - AXLE LARGE UDI-DI code: 08033390128872 Lot/Serial Numbers: 22276962300054 23325482400047 24006192400193
Root Cause
Process control
Action Taken
On 10/02/2024, the firm notified U.S. surgeons of the recall and the two U.S. distributors were informed via email on 10/11/2024. An updated/follow-up Recall Notification and Acknowledgement form is pending. The update/follow-up Recall Notification is informing surgeons and distributors that the firm has received a total of two similar complaints, regarding issues related to difficulty in disassembly of the axle component by using the screwdriver as per Surgical Technique. According to the internal investigation, the main concurring root causes of the problem seem to be the incomplete shot peening on the taper and the missing identification of a critical dimension (thread length). The Recall Notification informs surgeons to use other instruments available in the Operating Room to successfully complete the surgery or, in the worst case, several parts/the entire implant (both the humeral and the ulnar components) should be removed. Surgeons are also asked to Fill out, sign, and send the following Acknowledgement and Receipt Form via email as confirmation that You have read and acknowledged the content of this document. For questions or assistance, contact: Contact of the Importer: Kenneth Newman - Senior Regulatory Affairs Specialist (LimaCorporate now Enovis) /Recall Coordinator (Enovis) E-mail: Kenneth.Newman@enovis.com Or to the Manufacturer contact point: Federica Malvaso Post-Market Surveillance Lead (LimaCorporate now Enovis) E-mail: pms@enovis.com Distributors are instructed to: Check your stock to locate and quarantine the affected devices. Devices must be sent back to: Lima U.S.A., Inc. | 2001 NE Green Oaks Blvd. Ste.100 | Arlington, Texas 76006 | USA within 15 days together with a signed hard copy of the following Acknowledgement and Receipt Form.