medical Class II Updated 2018-05-23

Kelyniam Global, Inc. recalls Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (

Recalled Product

Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C. Case Numbers: CSI041216-CM1 CSI092016-LD1L

View official government recall

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