FDA recall Z-1317-2023

Product

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

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.

Distribution

US: MO

Key facts

Status

Ongoing

Initiation date

2023-02-21

Report date

2023-04-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Daniele Del Friuli, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1317-2023