[Recalled] Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002 — Significant design changes made to the Custom Skull Implant (CSI) devices, such… | FDA 2017-06-10
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002 |
|---|---|
| Brand / manufacturer | Kelyniam Global, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1871-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 10 June 2017 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.