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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 manufacturing issue, their is a potential for peripheral holes to be out of specification.
ProductREF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
Quantity13 units
DistributionUS Nationwide distribution in the states of MI, IL, ND, MO, OK.
Initiated2023-05-30
Classified2023-06-27
Recall numberZ-2010-2023
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-2010-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92459/

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