Altstatten Sg, Switzerland
Icotec Ag recalls
2 recalls recorded since 2018, most recently on 28 November 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 28 November 2023
- Reason
- icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently.
- Distribution
- US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0700-2024, Z-0701-2024
- VADER pedicle system, torque wrench, Catalog Number 42-702
- VADER pedicle system, torque wrench, Catalog Number 42-703
Terminated Class II Medical devices
- Recall started
- 3 November 2022
- Terminated
- 10 September 2026
- Reason
- During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm.
- Distribution
- US Nationwide distribution in the state of GA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0728-2023
- VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702
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.