Data Foundry

Medical device recalls 2024

PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates:… — Class II medical device recall Z-0726-2024

Ongoing recall by Limacorporate S.p.A, reported 2024-01-24, distributed in CA, IL, IN, MI, MO, OK. Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could

Recall numberZ-0726-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmLimacorporate S.p.A, San Daniele Del Friuli, N/A, Italy
Recall initiated2023-08-29
Classified2024-01-12
Reported by FDA2024-01-24
DistributedCA, IL, IN, MI, MO, OK
Quantity179
Reason classesspecification failure
UPC / GTIN / UDI-DI08033390231299, 08033390231312, 08033390244824, 08033390244848, 08033390244893, 08033390244909, 08033390244916, 08033390244923, 08033390244930, 08033390244947

Product

PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510, BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810, BASEPLATE D.25MM FULL WEDGED 15-degrees/1975.14.615, BASEPLATE D.28MM FULL WEDGED 15-degrees/1975.14.815, BASEPLATE D.28MM FULL WEDGED 15-degrees X/1975.14.865, BASEPLATE D.25 MM FULL WEDGED 20-degrees/1975.14.620, BASEPLATE D.28 MM FULL WEDGED 20-degrees/1975.14.820, BASEPLATE D.28 MM FULL WEDGED 20-degrees X/1975.14.870

Reason for recall

Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0726-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.