FDA Device recall Z-0415-2013
Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component
- FDA Device
- Class II
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class II recall of Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component by Biomet, citing the color code on label conflicts with the liner size (liner size 24 should be green, not yellow).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0415-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-04 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | US |
Product
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
Reason
The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)
Identifiers
| code_info | Part 11-106054 Lot 528310 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0415-2013%22
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