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.
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
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.
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.
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.
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.
Review the UDI-DI code and lot numbers on your prosthesis to confirm if it matches the recalled units listed in the recall notice.
The recall is due to a potential difference in mechanical behavior between the implanted device and the surgical tools used during revision surgery, which could cause complications.
The affected models are TEMA Elbow - Axle Small (REF 1590.15.010) and TEMA Elbow - Axle Large (REF 1590.15.020).
Check the UDI-DI code and lot numbers on your prosthesis against the specific numbers listed in the recall notice.
We’ve drafted a message you can send Limacorporate to request your refund or repair — edit it as you like.
Subject: Recall Z-0744-2025 — Limacorporate Limacorporate Hello, I own a Limacorporate that is covered by recall Z-0744-2025 from Limacorporate. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
