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TEMA Elbow recallZ-0744-2025 · Limacorporate S.p.A · initiated Oct 2, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Limacorporate S.p.A or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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: [email protected] Or to the Manufacturer contact point: Federica Malvaso Post-Market Surveillance Lead (LimaCorporate now Enovis) E-mail: [email protected] 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.

Recall details

Recall number
Z-0744-2025
Status
Open, Classified
Initiated by the company
Oct 2, 2024
Posted by the FDA
Dec 20, 2024
Recalling firm
Limacorporate S.p.A
Quantity
~87 devices (U.S.)
Product code
JDB
FDA submissions
K222807
Distribution
U.S: FL and TX O.U.S.: N/A

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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