Limacorporate recalls TEMA Axle Small (REF 1590.15.010) due to an unapproved component in its elbow prosthesis. Affected users should contact the manufacturer for details.
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
Limacorporate is recalling TEMA Axle Small (REF 1590.15.010) because it contains an unapproved component that isn't cleared for U.S. use. This could pose a safety risk if the prosthesis is used without proper approval.
The prosthesis includes a component that has not been approved for marketing in the U.S. This unapproved part could lead to safety issues if the device is used without proper regulatory clearance.
Users of the TEMA Axle Small elbow prosthesis with the specific model number REF 1590.15.010 are most at risk. The recall applies to those who purchased the product from authorized channels.
Check for the model number REF 1590.15.010 on the product label. The product was sold with specific lot numbers including 2115522 and sterilization lot 2100241.
Look for the model number REF 1590.15.010 on the product label to confirm if it is affected.
The TEMA Axle Small includes an unapproved component that is not cleared for U.S. marketing, which could pose safety risks.
The recall record states that additional information is pending the manufacturer's product label, so contact Limacorporate directly for specific instructions.
The recall record does not specify a deadline for action.
We’ve drafted a message you can send Limacorporate to request your refund or repair — edit it as you like.
Subject: Recall Z-1261-2023 — Limacorporate Limacorporate Hello, I own a Limacorporate that is covered by recall Z-1261-2023 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.
