Chicago, IL, United States
Clariance Inc recalls
1 recall recorded since 2018, most recently on 1 July 2019. 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
- 1 July 2019
- Terminated
- 9 July 2020
- Reason
- Potential for the polyaxial screw to become disassembled during implant.
- Distribution
- Nationwide distribution to CA, IL, IN, NY, OH, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1986-2019
- Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-L
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.