QQ463

Stapes Prostheses Nitinol/PTFE, 1 piece, sterile, Wire diam: 0.2 mm, PTFE shaft diam: 0.4 & 0.6 mm, Incus diam. small standard, large; length 5.25, 5.50, 5.75, 7.00 (shortenable) Stapes Prostheses Platinum/PTFE, 1 piece, sterile; piston diam. 0.4 & 0.6 mm; length 5.25, 5.50, 5.75, 7.00 (shortenable), 10.00 (shortenable) Stapes Prostheses Titanium, 1 piece, sterile; piston diam. 0.4 & 0.6 mm; length 5.25, 5.50, 5.75, 8.00 (shortenable)

For reconstruction of the sound conduction chain between middle ear and inner ear through replacement of the stapes. The body of the implant consists of a columella (which in some product versions can be shortened) and a flat band. The columella is inserted in the opened Vestibulum auris through the trepanated stapes foot-plate. The flat band is placed around the long process of the incus. The implants are available in various versions and materials: • Titanium: Columella and flat band made of titanium; • Platinum/PTFE: Columella made of polytetrafluoroethylene (PTFE), flat band made of platinum (Pt); • Nitinol/PTFE: Columella made of polytetrafluoroethylene (PTFE), flat band made of nitinol.

Count and link only, sourced from the TGA's Database of Recalls, Product Alerts and Product Corrections. "Market actions" includes recalls, product alerts and product corrections — full detail stays on the TGA's own site.