RecallRadar

FDA Device recall Z-0524-2024

PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

On 2023-12-20 the FDA classified a Class II recall of PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 by Limacorporate S P A, citing due to incorrect product labeling.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0524-2024
ClassificationClass II
Statusongoing
Initiated2023-10-27
Published2023-12-20
Last updated2026-09-13 11:56 UTC
CompanyLimacorporate S P A
DistributionAZ, CA, IL, LA, NY

Product

PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

Reason

Due to incorrect product labeling

Identifiers

code_infoProduct Code: 6539.54.610 UDI-DI Code: 08033390212786 Lot/Sterilization Numbers: 2122621 / 2200149 2203871 / 2200167

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0524-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.