ExploR 7x26mm Modular Radial Stem — Class II medical device recall Z-1615-2014
Terminated recall by Biomet, Inc., reported 2014-05-21, distributed nationwide. This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads ar
| Recall number | Z-1615-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-04-22 |
| Classified | 2014-05-13 |
| Reported by FDA | 2014-05-21 |
| Terminated | 2015-01-13 |
| Distributed | Nationwide (US) |
| Quantity | 8 devices |
| Model numbers | 11-210062 |
Product
ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1615-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.