Z-0726-2024Class II

PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/

Name: Z-0726-2024 PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/
Creator: Limacorporate S.p.A
Published: 2023-08-29
License: https://open.fda.gov/license/

Limacorporate S.p.A. / initiated 2023-08-29 / Open, Classified / root cause: design

FDA source

Limacorporate S.p.A began a recall of 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... on 2023-08-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0726-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-29
Posted: 2024-01-12
Recalling firm: Limacorporate S.p.A.
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
Product code: MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 8/29/23, the firm phoned all agents and surgeons to immediately stop surgeries with affected devices. On 10/10/23 the firm emailed recall notices to customers asking them to take the following actions: 1) Surgeons are suggested to perform a short-term patient s monitoring (radiographs at 6 weeks, 3-6 months and 1 year might be considered) and acting accordingly, based on a case-by-case evaluation. 2) Locate, quarantine, and return affected devices. Complete and return the response form to [email protected] 3) Customers with questions can email the firm at [email protected]
Quantity in commerce: 179
Distribution: US: IL, MO, CA, IN, MI, OK
Product codes and lots: Product Code/UDI-DI: 1975.14.500/08033390244824, 1975.14.800/08033390244893, 1975.14.510/08033390231299, 1975.14.810/08033390244909, 1975.14.615/08033390244848, 1975.14.815/08033390244916, 1975.14.865/08033390244930, 1975.14.620/08033390231312, 1975.14.820/08033390244923, 1975.14.870/08033390244947

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0726-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0726-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-12

Product code MBF

K222427Class IIPRIMA TT GlenoidLima Corporate S.P.A. / cleared 2022-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)