FDA (Devices) recall action 79791
The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Kelyniam Global is recalling 23 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for clearance.
Kelyniam Global is recalling 54 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for clearance.
Kelyniam Global is recalling two Custom Skull Implants because significant design changes were not validated or submitted to the FDA for marketing clearance.
Kelyniam Global is recalling 16 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for marketing clearance.