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Ascension Orthopedics, Inc recalls Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
Recalled February 13, 2019 · FDA recall Z-0794-2019 · Ascension Orthopedics
Hazard
The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant). · FDA Class III
Sold at
Distributed to accounts in MO. Foreign distribution to Korea and Thailand.
Description
The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
Product
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
Manufacturer(s)
Ascension Orthopedics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →