FDA Medical Device Recalls (openFDA)
Limacorporate S.p.A: PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
- Recall number
- Z-0524-2024
- Recalling firm
- Limacorporate S.p.A
- Product
- PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
- Status
- Open, Classified
- Initiated
- 2023-10-27
- Posted
- 2023-12-09
- Terminated
- not on file
- Reason
- Due to incorrect product labeling
- 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 medicalcomplaints@limacorporate.com.
- Quantity
- 33 devices
- Distribution
- U.S Distribution: AZ, CA, IL, LA, and NY
- Lot, serial or model codes
- Product Code: 6539.54.610 UDI-DI Code: 08033390212786 Lot/Sterilization Numbers: 2122621 / 2200149 2203871 / 2200167
- 510(k) numbers
- ["K213381"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3008021110
- Firm city
- San Daniele Del Friuli
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28