FDA Device recall Z-0794-2019
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
- FDA Device
- Class III
- terminated
- Published 2019-02-13
On 2019-02-13 the FDA classified a Class III recall of Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW by Ascension Orthopedics, citing the product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0794-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-11-16 |
| Published | 2019-02-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ascension Orthopedics |
| Distribution | MO |
Product
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
Reason
The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
Identifiers
| code_info | 170691 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0794-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.