Kelyniam Custom Skull Implant Recall for Unvalidated Design Changes
Kelyniam Global is recalling 23 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for 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 is classified as FDA Class II. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).
Plain-English summary
Kelyniam Global, Inc. is recalling 23 units of the Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003. 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 without proper validation or submission to the FDA for marketing clearance. These changes included removing pressure relief holes across the length of the device and adding suture holes along the ridge of the implant. Additionally, the Temporal Suture System (TSS) is no longer being offered, and the Integrated Fixation System (IFS) has been temporarily suspended.
Patients who have received these implants should contact their healthcare provider for guidance. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
- Manufacturer
- Kelyniam Global, Inc.
- Category
- Medical Device — Implants
- Affected units
- 23
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 Recalled 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