Recall Z-1873-2018 ยท GXN Plate, Cranioplasty, Preformed, Non-Alterable
Kelyniam Global, Inc.
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
| Date | Jun 10, 2017 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Device Design |
| Action | 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 (IF |
| Quantity | 54 |
| Distribution | US nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103582 | KELYNIAM CUSTOM SKULL IMPLANT (CSI) Kelyniam Global, Inc., Apr 14, 2011 |