Kelyniam Custom Skull Implant — Class II medical device recall Z-1873-2018
Terminated recall by Kelyniam Global, Inc., reported 2018-05-23, distributed nationwide. Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief ho
| Recall number | Z-1873-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kelyniam Global, Inc., Collinsville, CT, United States |
| Recall initiated | 2017-06-10 |
| Classified | 2018-05-14 |
| Reported by FDA | 2018-05-23 |
| Terminated | 2020-09-14 |
| Distributed | Nationwide (US) |
| Quantity | 54 |
| Model numbers | PEEK-IM1004 |
Product
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1873-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.