Z-2009-2023Class II

REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R

Name: Z-2009-2023 REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Creator: Limacorporate S.p.A
Published: 2023-05-30
License: https://open.fda.gov/license/

Limacorporate S.p.A. / initiated 2023-05-30 / Open, Classified / root cause: design

FDA source

Limacorporate S.p.A began a recall of REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R on 2023-05-30. FDA classified it as Class II and gives the reason as "Due to manufacturing issue, their is a potential for peripheral holes to be out of specification". 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-2009-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-30
Posted: 2023-06-27
Recalling firm: Limacorporate S.p.A.
Product: REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Product code: MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Reason for recall: Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
Root cause tag: design
FDA root cause: Device Design
Action: On May 30, 2023 LimaCorporate issued an Urgent: Medical device Recall notification via E-Mail. LimaCorporate asked consignees to take the following actions: 1. Check your stock to locate and quarantine the affected devices. Devices must be sent back to your Lima local reference within 15 days together with a hard copy of the attached Response Form at the following address: Lima U.S.A., Inc. | 2001 NE Green Oaks Blvd. Ste.100 | Arlington, Texas 76006 | USA 2. Fill out, sign and send the attached Response Form via email to your Lima local reference at [email protected] as a confirmation that You have read and acknowledged the content of this FSN. 3. If If needed, please address any inquiry to the email address [email protected].
Quantity in commerce: 13 units
Distribution: US Nationwide distribution in the states of MI, IL, ND, MO, OK.
Product codes and lots: UDI-DI: 08033390244824; All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2009-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2009-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-27
Z-2010-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-27

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)