Ascension Modular Radial Head — Class III medical device recall Z-0794-2019
Terminated recall by Ascension Orthopedics, Inc, reported 2019-02-13. The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ Sy
| Recall number | Z-0794-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascension Orthopedics, Inc, Austin, TX, United States |
| Recall initiated | 2018-11-16 |
| Classified | 2019-02-01 |
| Reported by FDA | 2019-02-13 |
| Terminated | 2019-11-22 |
| Countries outside the US | KR, TH |
| Model numbers | MRH-350-04-WW |
Product
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
Reason for recall
The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
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-0794-2019. 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.