FDA-Device2012-11-28Class II
Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery. Cemented or non-cemented total hip replacement . The device is intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a
Biomet, Inc.
Hazard
The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)
Sold states
Nationwide Distribution including CA, IN, NC, OH, and UT.
Affected count
16 (5 USA)
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery. Cemented or non-cemented total hip replacement . The device is intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0415-2013Don't want to check this manually?
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