Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0794-2019.
The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0794-2019.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Ascension Orthopedics, Inc or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0794-2019.
Ascension Orthopedics, Inc
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Ascension Orthopedics, Inc Recall FAQ
Ascension Orthopedics, Inc is the subject of a medical implants safety report: Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW. The notice was published on November 16, 2018 by the U.S. Food and Drug Administration (FDA). Approximately 0 units are potentially affected.