FDAFDA · Food and drugs·Recall number Z-0794-2019
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
Published February 13, 2019 · Recall initiated: November 16, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Ascension Orthopedics, Inc
- Distributor
- Distributed to accounts in MO. Foreign distribution to Korea and Thailand.
- Lot
- 170691
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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