Ascension Orthopedics, Inc recalls Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
- Recall date
- November 16, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0794-2019
- FDA classification
- Class III
- Brand / firm
- Ascension Orthopedics, Inc
- Sold / distributed
- Distributed to accounts in MO. Foreign distribution to Korea and Thailand.
Why it was recalled
The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
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