Austin, TX, United States
Ascension Orthopedics, Inc recalls
1 recall recorded since 2018, most recently on 16 November 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 16 November 2018
- Terminated
- 22 November 2019
- Reason
- The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
- Distribution
- Distributed to accounts in MO. Foreign distribution to Korea and Thailand.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0794-2019
- Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.