# FDA recall Z-1872-2018

> **Kelyniam Global, Inc.** · Class II · device recall initiated 2017-06-10.

## Product

Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003

## 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

## Distribution

US nationwide distribution.

## Key facts

- **Recall number:** Z-1872-2018
- **Recalling firm:** Kelyniam Global, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-10
- **Report date:** 2018-05-23
- **Termination date:** 2020-09-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Collinsville, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1872-2018

## Citation

> AI Analytics. FDA recall Z-1872-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-1872-2018. Source: US FDA. Licensed CC0.

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