Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
Class I - DangerousWhat Should You Do?
- Check if you have this product: Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C. Case Numbers: CSI082114-CT1 CSI081214-TB1 CSI020216-LK1 CSI092016-LD1R CSI100116-BM1A CSI092616-YB1 CSI092616-MM1 CSI112316-YB1 CSI050217-LS1 CSI052217-AF1 CSI062317-GM1 CSI071017-NS1B CSI071417-CM1 CSI102617-DL1 CSI101617-JF1A CSI102617-DL1
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Kelyniam Global, Inc.
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
Product Codes/Lot Numbers:
Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C. Case Numbers: CSI082114-CT1 CSI081214-TB1 CSI020216-LK1 CSI092016-LD1R CSI100116-BM1A CSI092616-YB1 CSI092616-MM1 CSI112316-YB1 CSI050217-LS1 CSI052217-AF1 CSI062317-GM1 CSI071017-NS1B CSI071417-CM1 CSI102617-DL1 CSI101617-JF1A CSI102617-DL1
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1871-2018
Related Recalls
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
Kelyniam Global
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
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
Kelyniam Global
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
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