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

Recall date

June 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1872-2018

FDA classification

Class II

Brand / firm

Kelyniam Global, Inc.

Sold / distributed

US nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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