TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented to
Summary
The FDA issued a Class II for TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.0 by Limacorporate S.p.A. Reason: Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery..
Details
Source
Device Recall
External ID
Z-0744-2025
Action Date
2025-01-01
Status
Ongoing
Category
device
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.
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
Quantity Affected: ~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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-02
Company
San Daniele Del Friuli
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Limacorporate S.p.A has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Limacorporate S.p.A) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Limacorporate S.p.A have FDA actions?
Limacorporate S.p.A has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0744-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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