Home / Recalls / Medical Devices
Kelyniam Global, Inc. recalls Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
Recalled May 23, 2018 · FDA recall Z-1871-2018 · Kelyniam Global
Hazard
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 · FDA Class II
Units
16
Sold at
US nationwide distribution.
Description
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
Product
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
Manufacturer(s)
Kelyniam Global, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →