FDA Device recall Z-1615-2014
ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062
- FDA Device
- Class II
- terminated
- Published 2014-05-21
On 2014-05-21 the FDA classified a Class II recall of ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062 by Biomet, citing this lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening fr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1615-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-22 |
| Published | 2014-05-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet |
| Distribution | US |
Product
ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Reason
This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the set screw loosens, a revision surgery may be necessary.
Identifiers
| code_info | Catalog Number: 11-210062 Lot Number Identification: 972230 |
|---|
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-1615-2014%22
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