Z-0415-2013 Class II Terminated
FDA device recall Z-0415-2013 was initiated by Biomet, Inc. on Oct 4, 2012 and is designated Class II. Reason for recall: The color code on label conflicts with the liner size (liner size 24 should be green, not yellow) The recall status is terminated (terminated Mar 18, 2013). Affected quantity: 16 (5 USA).
Recall Details
- Product Type
- Devices
- Report Date
- Nov 28, 2012
- Initiation Date
- Oct 4, 2012
- Termination Date
- Mar 18, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 (5 USA)
Product Description
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 for Recall
The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)
Distribution Pattern
Nationwide Distribution including CA, IN, NC, OH, and UT.
Code Information
Part 11-106054 Lot 528310
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0415-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026