FDA recall Z-0524-2024

Limacorporate S.p.A · Class II · device

Product

PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

Reason for recall

Due to incorrect product labeling

Distribution

U.S Distribution: AZ, CA, IL, LA, and NY

Key facts

Status
Ongoing
Initiation date
2023-10-27
Report date
2023-12-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Daniele Del Friuli, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0524-2024