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Recall

Class II — Limacorporate S.p.A

Recalling firmLimacorporate S.p.A.
Registered facilityView this company's 3 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonDue to incorrect product labeling
ProductPHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Quantity33 devices
DistributionU.S Distribution: AZ, CA, IL, LA, and NY
Initiated2023-10-27
Classified2023-12-09
Recall numberZ-0524-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Limacorporate S.p.A (Z-0524-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93329/

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