FDA Device recall Z-1870-2018
Kelyniam Custom Skull Implant (CSI), Model no
- FDA Device
- Class II
- terminated
- Published 2018-05-23
On 2018-05-23 the FDA classified a Class II recall of Kelyniam Custom Skull Implant (CSI), Model no by Kelyniam Global, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1870-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-10 |
| Published | 2018-05-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Kelyniam Global |
| Distribution | US |
Product
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
Reason
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
Identifiers
| code_info | Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C. Case Numbers: CSI041216-CM1 CSI092016-LD1L |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1870-2018%22
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