Collinsville, CT, United States
Kelyniam Global, Inc. recalls
1 recall recorded since 2018, most recently on 10 June 2017. 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 II Medical devices
- Recall started
- 10 June 2017
- Terminated
- 14 September 2020
- Reason
- Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant, were not validated or submitted to FDA for marketing clearance. The Temporal Suture System (TSS) is no longer being offered and the Integrated Fixation System (IFS) has been temporarily suspended
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1872-2018, Z-1873-2018, Z-1870-2018, Z-1871-2018
- Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
- Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
- Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
- Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
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.