Z-0794-2019 Class III Terminated

Recalled by Ascension Orthopedics, Inc — Austin, TX

Recall Details

Product Type
Devices
Report Date
February 13, 2019
Initiation Date
November 16, 2018
Termination Date
November 22, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW

Reason for Recall

The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).

Distribution Pattern

Distributed to accounts in MO. Foreign distribution to Korea and Thailand.

Code Information

170691