Limacorporate TEMA Elbow Prostheses Recall: Potential Surgical Risk
Limacorporate recalls TEMA Elbow - Axle Small and Large models due to potential mechanical mismatch during revision surgery. Affected units have specific UDI-DI codes and lot numbers.
Recall notice
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
Contact the company
What happened, in plain English
Limacorporate is recalling two types of cemented total elbow prostheses (TEMA Elbow - Axle Small and Large) because they might not work correctly with surgical tools during revision surgery. This could lead to complications if the device doesn't match the tools used in the procedure. Read more at govinfonow.com/recall/53834-limacorporate-tema-elbow-prostheses-recall-potential-surgical-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/53834-limacorporate-tema-elbow-prostheses-recall-potential-surgical-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0744-2025
Cite this page
“Limacorporate TEMA Elbow Prostheses Recall: Potential Surgical Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53834-limacorporate-tema-elbow-prostheses-recall-potential-surgical-risk. Based on FDA recall #Z-0744-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0744-2025%22&limit=1).
Why it’s dangerous
The prostheses might have different mechanical behavior compared to the surgical tools used during revision surgery. This mismatch could cause complications during the procedure, such as improper fitting or movement of the device.
Who’s affected
Patients who received the TEMA Elbow - Axle Small (REF 1590.15.010) or TEMA Elbow - Axle Large (REF 1590.15.020) prostheses during revision surgery are most at risk. The recall applies to specific units with listed UDI-DI codes and lot numbers.
How to tell if you have this one
Check for the product catalog numbers 1590.15.010 (Axle Small) or 1590.15.020 (Axle Large) with specific UDI-DI codes and lot numbers listed in the recall notice.
- Brand
Limacorporate- Category
Medical device
What to do — step by step
Check Product Details
Review the UDI-DI code and lot numbers on your prosthesis to confirm if it matches the recalled units listed in the recall notice.
Where it went and when
Where it was distributed
Distributed in Florida and Texas.
FDA distribution: “U.S: FL and TX O.U.S.: N/A” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Texas.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0744-2025 (October 2, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0744-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.