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

Recall Insight

This FDA Devices action (record #Z-1873-2018) was formally reported on May 23, 2018, with the manufacturer initiating the action on June 10, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Kelyniam Global, Inc. is listed as the recalling firm, operating out of Collinsville, CT. Federal records indicate 54 units are affected.

The documented reason for this recall is: 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 validate… Distribution data in the federal record shows the product reached: US nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 8 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.