Lower risk Medical device recall · FDA · Published October 27, 2023

Limacorporate PHYSICA HPS Tibial Liner #6 H10 Recall Due to Incorrect Labeling

Limacorporate recalls PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 due to incorrect product labeling. Affected units include specific lot numbers and serial codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0524-2024Medical device Limacorporate ›

Lower-risk recall

Due to incorrect product labeling

Take action

Contact the company

Recalling firmLimacorporate S.p.AVia Nazionale 52, Di San Daniele · San Daniele Del Friuli, Italy

✎ GovInfoNow plain-language explainer

Limacorporate is recalling a specific model of Tibial Liner due to incorrect product labeling. This issue does not pose a safety risk but requires correction to ensure proper identification. Read more at govinfonow.com/recall/56995-limacorporate-physica-hps-tibial-liner-6-h10-recall-due-to.

Source Summary by GovInfoNow · govinfonow.com/recall/56995-limacorporate-physica-hps-tibial-liner-6-h10-recall-due-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0524-2024

Cite this page

“Limacorporate PHYSICA HPS Tibial Liner #6 H10 Recall Due to Incorrect Labeling.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56995-limacorporate-physica-hps-tibial-liner-6-h10-recall-due-to. Based on FDA recall #Z-0524-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0524-2024%22&limit=1).

The FDA announced on 2023-10-27 that Limacorporate S.p.A. is recalling the PHYSICA HPS Tibial Liner #6 H10 due to incorrect product labeling, according to the FDA.

How to tell if you have it

Brand: Limacorporate
Product: PHYSICA HPS Tibial Liner #6 H10
REF: 6539.54.610
Product Code: 6539.54.610
UDI-DI Code: 08033390212786
Lot/Sterilization Numbers: 2122621 / 2200149, 2203871 / 2200167
Quantity: 33 devices
Distribution: AZ, CA, IL, LA, and NY

The hazard

The recall is due to incorrect product labeling, according to the FDA.

Context

GovInfoNow's records show Limacorporate S.p.A. has had 8 other recalls since 2017-09-08. Other recent recalls of similar products include EMPOWR 3D Knee Implants (2026-01-15), Medline TRACH Tube Kit (2026-07-10), and Smith & Nephew BIOSURE HA Screw (2025-11-24).

How to tell if you have this one

Check for the product code 6539.54.610 and lot numbers 2122621, 2200149, 2203871, or 2200167 on the packaging or label.

Brand
Limacorporate
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the product code 6539.54.610 and lot numbers 2122621, 2200149, 2203871, or 2200167 on the packaging or label.

Where it went and when

Where it was distributed

Distributed in 5 states.

FDA distribution: “U.S Distribution: AZ, CA, IL, LA, and NY” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Illinois, Louisiana, New York.

Recall timeline

FDA published this recall 54 days after the firm started it.

Oct 27, 2023Firm started the recall
Dec 9, 2023FDA classified it Class II
Dec 20, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Limacorporate recalls

Link to this recall

<a href="https://govinfonow.com/recall/56995-limacorporate-physica-hps-tibial-liner-6-h10-recall-due-to">Limacorporate PHYSICA HPS Tibial Liner #6 H10 Recall Due to Incorrect Labeling (GovInfoNow)</a>

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-0524-2024 (October 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0524-2024 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.