Limacorporate TEMA Elbow Prosthesis Recalled for Tool Incompatibility

Agency Publication Date: December 20, 2024

Summary

Limacorporate S.p.A has recalled approximately 87 units of its TEMA Elbow System, including both small and large axle components. This cemented total elbow prosthesis is being recalled because there is a potential mechanical mismatch between the implanted device and the surgical tools required to remove or adjust it during future revision surgeries. While no injuries have been reported, patients with these specific axle models may experience complications if they require follow-up surgery.

Risk

The difference in mechanical behavior between the elbow implant and the specialized surgical tools used for revision may cause the tools to not function correctly during a procedure. This could lead to surgical delays, difficulty during surgery, or other medical complications for patients requiring revision of the prosthesis.

What You Should Do

This recall involves the TEMA Elbow System Axle Small (model 1590.15.010) and Axle Large (model 1590.15.020) total elbow prostheses.
Hospital staff and surgeons should identify affected units by checking the catalog and serial numbers listed on the product labeling or in hospital inventory records.
For the small axle (1590.15.010), look for serial numbers 23031752300054, 23177372300230, and 23173852400087.
For the large axle (1590.15.020), look for serial numbers 22276962300054, 23325482400047, and 24006192400193.
Stop using the recalled devices immediately and quarantine any affected inventory.
Contact Limacorporate S.p.A or your distributor directly to arrange for the return, replacement, or correction of the affected axles.
Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional assistance or questions regarding medical device recalls.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: TEMA Elbow - Axle Small

Variants: Cemented total elbow prosthesis

Model / REF:

1590.15.010

Serial Numbers:

23031752300054

23177372300230

23173852400087

UDI:

08033390128865

Small Axle variant

Product: TEMA Elbow - Axle Large

Variants: Cemented total elbow prosthesis

Model / REF:

1590.15.020

Serial Numbers:

22276962300054

23325482400047

24006192400193

UDI:

08033390128872

Large Axle variant

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95732

Status: Active

Manufacturer: Limacorporate S.p.A

Sold By: Specialty medical distributors; Hospitals

Manufactured In: Italy

Units Affected: ~87 devices (U.S.)

Distributed To: Florida, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall involves the TEMA Elbow System Axle Small (model 1590.15.010) and Axle Large (model 1590.15.020) total elbow prostheses.

Hospital staff and surgeons should identify affected units by checking the catalog and serial numbers listed on the product labeling or in hospital inventory records.

For the small axle (1590.15.010), look for serial numbers 23031752300054, 23177372300230, and 23173852400087.

For the large axle (1590.15.020), look for serial numbers 22276962300054, 23325482400047, and 24006192400193.

Stop using the recalled devices immediately and quarantine any affected inventory.

Contact Limacorporate S.p.A or your distributor directly to arrange for the return, replacement, or correction of the affected axles.

Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional assistance or questions regarding medical device recalls.

Affected Products

Product: TEMA Elbow - Axle Small

Variants: Cemented total elbow prosthesis

Model / REF:

1590.15.010

Serial Numbers:

23031752300054

23177372300230

23173852400087

UDI:

08033390128865

Small Axle variant

Product: TEMA Elbow - Axle Large

Variants: Cemented total elbow prosthesis

Model / REF:

1590.15.020

Serial Numbers:

22276962300054

23325482400047

24006192400193

UDI:

08033390128872

Large Axle variant