TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total el

FDA device recall Z-0744-2025 · posted 2024-12-20 · Open, Classified

Recall details

Recalling firm

Limacorporate S.p.A

Reason for recall

Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.

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.

Root cause

Process control

Status

Open, Classified

Product code

JDB

Quantity affected

~87 devices (U.S.)

Distribution

U.S: FL and TX O.U.S.: N/A

Date initiated

2024-10-02

Date posted

2024-12-20

Location

San Daniele Del Friuli, Italy

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