Home / Recalls / Kelyniam Global, Inc. / Z-1871-2018

Z-1871-2018 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
16

Product Description

Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002

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: 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

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-1870-2018 Class II — Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small) (June 10, 2017)