Recall Z-1317-2023— Limacorporate S.p.A

Name: FDA recall Z-1317-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-21

Class II · Ongoing

Class II FDA medical device recall by Limacorporate S.p.A, initiated 2023-02-21. It names one FDA 510(k) clearance: K163397. Product: SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210. Reason: 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..

Recalling firm: Limacorporate S.p.A
Classification: Class II
Status: Ongoing
Initiated: 2023-02-21
Firm location: San Daniele Del Friuli, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K163397 — SMR Hybrid Glenoid SystemLima Corporate S.P.A.·cleared 2017-06-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.