Z-1465-2013 Class II Terminated
FDA device recall Z-1465-2013 was initiated by Biomet, Inc. on Apr 26, 2013 and is designated Class II. Reason for recall: Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes… The recall status is terminated (terminated Aug 29, 2013). Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 12, 2013
- Initiation Date
- Apr 26, 2013
- Termination Date
- Aug 29, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
Reason for Recall
Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. The implant itself is etched with the correct O.D. size.
Distribution Pattern
Distributed in New York.
Code Information
Part numbers: EP-200162, EP-200162, EP-200164, and EP-200166 with Lot numbers: 027050, 101470, 115950, 101480, 247990, 948810, 967270, 027070, 287820, 729870, and 860880.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1465-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026