FDA-Device2023-04-05Class II
SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Limacorporate S.p.A
Hazard
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.
Sold states
US: MO
Affected count
1
Manufactured in
Via Nazionale 52, Di San Daniele, San Daniele Del Friuli, N/A, Italy
Products
SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1317-2023Don't want to check this manually?
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