medical Class II Updated 2018-05-23

Kelyniam Global, Inc. recalls Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004

Recalled Product

Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004

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: CSI070314-JF1 CSI082214-EC1 CSI090314-CG1 CSI091614-JB1 CSI101414-RA1 CSI110514-SS2 CSI120814-JC1 CSI121114-DD1 CSI121614-LG1 CSI121714-OL1 CSI011615-AC1 CSI012915-JG1 CSI012915-SS1 CSI022415-HL1 CSI040615-RA1 CSI060115-EB1 CSI102215-CT1 CSI112415-ES1 CSI101615-BE1 CSI012016-RT1B CSI022916-CS1 CSI032216-SP1 CSI020216-JR1 CSI051716-TM1 CSI070516-AT1 CSI070116-EG1 CSI072816-JE1 CSI092716-AV1 CSI101416-TY1 CSI110816-CS1 CSI112316-NK1 CSI092616-CB1 CSI111516-RB1 CSI113016-NR1 CSI111616-FH1 CSI010517-JH1 CSI041417-KK1 CSI060117-AR1 CSI062617-LV1 CSI071017-NS1A CSI081717-GG1 CSI081717-JM1 CSI082717-LH1 CSI082917-UK1 CSI081717-JM1 CSI090617-JH2 CSI092717-DH1 CSI092617-OT1 CSI100417-EZ1 CSI100517-AE1 CSI100617-MH1 CSI101817-KD1 CSI102617-NK1 CSI101617-JF1B
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