PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 recallZ-0524-2024 · Limacorporate S.p.A · initiated Oct 27, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Limacorporate S.p.A or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to incorrect product labeling
FDA root cause category: Labeling Change Control
What the company is doing
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].
Recall details
- Recall number
- Z-0524-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 27, 2023
- Posted by the FDA
- Dec 9, 2023
- Recalling firm
- Limacorporate S.p.A
- Quantity
- 33 devices
- Product code
- JWH
- FDA submissions
- K213381
- Distribution
- U.S Distribution: AZ, CA, IL, LA, and NY
Product description
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Code information (models, lots, serial numbers)
Product Code: 6539.54.610 UDI-DI Code: 08033390212786 Lot/Sterilization Numbers: 2122621 / 2200149 2203871 / 2200167
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PHYSICA HPS 6539.54.610Limacorporate SPA · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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