Class II — Kelyniam Global, Inc.
| Recalling firm | Kelyniam Global Inc. |
|---|---|
| Registered facility | KELYNIAM GLOBAL INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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 |
| Product | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small) |
| Quantity | 2 |
| Distribution | US nationwide distribution. |
| Initiated | 2017-06-10 |
| Classified | 2018-05-14 |
| Terminated | 2020-09-14 |
| Recall number | Z-1870-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Kelyniam Global, Inc. (Z-1870-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79791/
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