Warsaw, IN, United States
Medartis Inc. recalls
1 recall recorded since 2018, most recently on 12 April 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 12 April 2024
- Reason
- Screw is 16mm long instead of 22mm long.
- Distribution
- Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1821-2024
- APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
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.