RegWardenFDA facility compliance records
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
ReasonShoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint space, central TT peg position and cement mantel observation.
ProductSMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Quantity1
DistributionUS: MO
Initiated2023-02-21
Classified2023-03-30
Recall numberZ-1317-2023
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-1317-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91869/

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