FDA Recall
Open, Classified
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Recall: Z-0524-2024
·
Initiated October 27, 2023
Recall
- Recall Number
- Z-0524-2024
- Event Number
- 93329
- Firm
- Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy
- FEI Number
- 3008021110
- Product Code
- JWH
- Status
- Open, Classified
- Root Cause
- Labeling Change Control
- Initiated
- October 27, 2023
- Posted
- December 9, 2023
Description
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Reason
Due to incorrect product labeling
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].
Distribution
U.S Distribution: AZ, CA, IL, LA, and NY
Quantity
33 devices