PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
This recall is currently active, issued December 9, 2023. It was issued by Limacorporate S.P.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy.
- Recall Initiated
- October 27, 2023
- Posted
- December 9, 2023
- Recall Number
- Z-0524-2024
- Quantity
- 33 devices
- Official Source
- View on FDA website ↗
Reason for Recall
Due to incorrect product labeling
Distribution
U.S Distribution: AZ, CA, IL, LA, and NY
Lot / Code Info
Product Code: 6539.54.610 UDI-DI Code: 08033390212786 Lot/Sterilization Numbers: 2122621 / 2200149 2203871 / 2200167
Root Cause
Labeling Change Control
Action Taken
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.