Z-1870-2018 Class II Terminated
FDA device recall Z-1870-2018 was initiated by Kelyniam Global, Inc. on June 10, 2017 and is designated Class II. 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… The recall status is terminated (terminated September 14, 2020). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- June 10, 2017
- Termination Date
- September 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
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 Pattern
US nationwide distribution.
Code Information
Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C. Case Numbers: CSI041216-CM1 CSI092016-LD1L