Kelyniam Custom Skull Implant Recalled for Unvalidated Design Changes
Kelyniam Global is recalling 16 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for marketing clearance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with unvalidated design changes that were not submitted for FDA clearance, representing a risk-of-harm product where specific injury reports are not detailed in the source text.
Plain-English summary
Kelyniam Global, Inc. is recalling 16 units of the Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002. The recall covers devices distributed nationwide in the United States. Specific case numbers for the affected units are listed in the official recall documentation.
The recall was initiated because significant design changes were made to the devices, including the removal of pressure relief holes across the length of the device and the addition of suture holes along the ridge of the implant. These modifications were not validated or submitted to the FDA for marketing clearance. Additionally, the Temporal Suture System (TSS) is no longer being offered, and the Integrated Fixation System (IFS) has been temporarily suspended.
Healthcare providers and patients who have received these specific implants should contact Kelyniam Global, Inc. for further instructions regarding the recall and potential replacement or removal of the devices.
The recalled product
- Product
- Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
- Manufacturer
- Kelyniam Global, Inc.
- Category
- Medical Device — Implant
- Affected units
- 16
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Kelyniam Global, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Kelyniam Global, Inc.
See all →- HighKelyniam Custom Skull Implant Recall for Unvalidated Design Changes
FDA (Devices) · 2018-05-23
- HighKelyniam Custom Skull Implant Recalled for Unvalidated Design Changes
FDA (Devices) · 2018-05-23
- HighKelyniam Custom Skull Implant Recalled for Unvalidated Design Changes
FDA (Devices) · 2018-05-23