FDA recall Z-1872-2018

Product

Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003

Reason for recall

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.

Key facts

Status

Terminated

Initiation date

2017-06-10

Report date

2018-05-23

Termination date

2020-09-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Collinsville, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1872-2018