Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1871-2018 — Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002

U.S. FDA — Device Enforcement · United States · 2017-06-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1871-2018
Date of alert
2017-06-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Kelyniam Global, Inc.
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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