Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Brand
Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Product Code: 6539.54.610 UDI-DI Code: 08033390212786 Lot/Sterilization Numbers: 2122621 / 2200149 2203871 / 2200167
Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy is recalling PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 due to Due to incorrect product labeling. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to incorrect product labeling
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, IL, LA, NY
Page updated: Jan 10, 2026