FDAJune 10, 2017device
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
Official recall recorded by the U.S. Food & Drug Administration.
The 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
What to do
FDA enforcement status: Terminated
Brands named
kelyniam globalkelyniam
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDASAFE-T-FILL Plastic Blood Gas Capillary Tubes, 150 ¿L; Prepared with Sodium Heparin Model/Catalog Number: 06 0007 Product Description: A clear, plastic capillary blood collection tube2025-09-26
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