Z-0794-2019 Class III Terminated
FDA device recall Z-0794-2019 was initiated by Ascension Orthopedics, Inc on November 16, 2018 and is designated Class III. 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). The recall status is terminated (terminated November 22, 2019).
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