Z-1317-2023Class II

SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210

Name: Z-1317-2023 SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Creator: Limacorporate S.p.A
Published: 2023-02-21
License: https://open.fda.gov/license/

Limacorporate S.p.A. / initiated 2023-02-21 / Open, Classified / root cause: manufacturing process

FDA source

Limacorporate S.p.A began a recall of SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 on 2023-02-21. FDA classified it as Class II and gives the reason as "Shoulder 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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1317-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-21
Posted: 2023-04-01
Recalling firm: Limacorporate S.p.A.
Product: SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Product code: MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Reason for recall: Shoulder 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 2/21/23, a recall notice was distributed to a customer who was asked to do the following: 1) Check your stock to locate and quarantine the affected devices. Devices must be sent back. 2) Complete, and return the response form to [email protected] 3) The recall notice should be shared with anyone who needs to be aware within your organization or shared with any organization where the potentially affected products have been transferred. Inquiries can be sent to [email protected]
Quantity in commerce: 1
Distribution: US: MO
Product codes and lots: UDI-DI/Lot/Expiration: 08033390121798/2206565/2027-04-30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1317-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1317-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-30

Product code MBF

K163397Class IISMR Hybrid Glenoid SystemLima Corporate S.P.A. / cleared 2017-06-29

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)