FDA Device recall Z-1465-2013
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty
- FDA Device
- Class II
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class II recall of Active Articulation E1. Intended for use with either primary or revision hip arthroplasty by Biomet, citing biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two confli….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1465-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-26 |
| Published | 2013-06-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | NY |
Product
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
Reason
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.
Identifiers
| code_info | Part numbers: EP-200162, EP-200162, EP-200164, and EP-200166 with Lot numbers: 027050, 101470, 115950, 101480, 247990,…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. |
|---|
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-1465-2013%22
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