Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003

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

On June 10, 2017, the recalling firm notified its Sales Representatives that effective June 10, 2017, the firm would no longer offer the temporal suture system (TSS). The firm requested that sales reps dispose of all marketing materials which contain details regarding the TSS. Sales reps who wanted to keep existing booklets in the field were asked to contact the firm to obtain adhesive labels to place over the discontinued product. On November 13, 2017, the recalling firm notified its Sales Representatives that the firm was temporarily suspending shipment of the Integrated Fixation System (IFS). The firm stated that all paper brochures were to be discarded, and asked sales reps to inform all those who received "Customize Skull and Craniofacial Implants" brochure and IFU. Revised marketing materials are available on the firm's website, www.kelyniam.com. If you have any questions, you may contact Dr. Mark V. Smith, Vice President of Kelyniam Global, Inc., at [email protected], or by phone at (800) 280-8192 x702.