Z-0524-2024Class II

PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

Name: Z-0524-2024 PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Creator: Limacorporate S.p.A
Published: 2023-10-27
License: https://open.fda.gov/license/

Limacorporate S.p.A. / initiated 2023-10-27 / Open, Classified / root cause: labeling and UDI

FDA source

Limacorporate S.p.A began a recall of PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 on 2023-10-27. FDA classified it as Class II and gives the reason as "Due to incorrect product labeling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0524-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-27
Posted: 2023-12-09
Recalling firm: Limacorporate S.p.A.
Product: PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Due to incorrect product labeling
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 10/27/2023, the firm sent via email an "URGENT: MEDICAL DEVICE RECALL" Letter to customer informing them that the firm was made aware of a mistake on the label of the HPS tibial liner #6H. 10mm. Customers are instructed to: Check their stock to locate and quarantine the affected devices. Devices must be sent back to the Lima local reference within 15 days together with a hard copy of the attached Acknowledgement and Receipt Form at the following address: Lima U.S.A., Inc. | 2001 NE Green Oaks Blvd. Ste.100 | Arlington, Texas 76006 | USA For questions or further assistance, email [email protected].
Quantity in commerce: 33 devices
Distribution: U.S Distribution: AZ, CA, IL, LA, and NY
Product codes and lots: Product Code: 6539.54.610 UDI-DI Code: 08033390212786 Lot/Sterilization Numbers: 2122621 / 2200149 2203871 / 2200167

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0524-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0524-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-12-20	2023-12-09

Product code JWH

K213381Class IIPhysica systemLima Corporate S.P.A. / cleared 2021-12-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)