UnratedMedical device recall · FDA · Published January 25, 2023
Limacorpor: TEMA Axle Small - Incorrect Component Risk
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.
“Limacorpor: TEMA Axle Small - Incorrect Component Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59006-limacorpor-tema-axle-small-incorrect-component-risk. Based on FDA recall #Z-1261-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1261-2023%22&limit=1).
The FDA announced on Jan. 25, 2023, that Limacorporate S.p.A. is recalling the TEMA Axle Small elbow prosthesis because it includes an incorrect component not cleared for U.S. marketing.
How to tell if you have it
Brand: Limacorporate
Product: TEMA Axle Small
REF: 1590.15.010
Product Code: 1590.15.010
UDI-DI Code: 08033390128865
Lot Number: 2115522
Sterilization Lot Number: 2100241
Quantity: 5 systems
Distribution: TX
The hazard
The recall is due to the inclusion of an incorrect component in the elbow prosthesis that is not cleared to be marketed in the U.S., according to the FDA.
Context
GovInfoNow's records show Limacorporate S.p.A. has issued eight other recalls since Sept. 8, 2017. Recent brand recalls include a May 19, 2025 recall for missing screws in the PRIMA 2MM Eccentric Adaptor and an Oct. 2, 2024 recall for potential surgical risks in TEMA Elbow Prostheses. Other recent recalls of similar products include Medline Convenience Kits with Unapproved Syringes Recalled: Design Changes Risk (Feb. 27, 2026) and Medline Convenience Kits with Unapproved Syringes: Recall for Design Changes (Feb. 27, 2026).
How to tell if you have this one
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.
Brand
Limacorporate
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the model number REF 1590.15.010 on the product label to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in Texas.
Listed by the agency
Not listed
FDA distribution: “U.S. Distribution to: TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Texas.
Recall timeline
FDA published this recall 56 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The recall record states that additional information is pending the manufacturer's product label, so contact Limacorporate directly for specific instructions.
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-1261-2023 (January 25, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1261-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.