Home / Recalls / Kelyniam Global, Inc. / Z-1870-2018

Z-1870-2018 Class II Terminated

Recalled by Kelyniam Global, Inc. — Collinsville, CT

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

Other recalls by Kelyniam Global, Inc.

  • Z-1873-2018 Class II — Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004 (June 10, 2017)
  • Z-1872-2018 Class II — Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003 (June 10, 2017)
  • Z-1871-2018 Class II — Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002 (June 10, 2017)