Kelyniam Custom Skull Implant Recalled for Unvalidated Design Changes
Kelyniam Global is recalling 54 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, a Class II recall without reported hospitalizations or fatalities falls under the 'High' severity category, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Kelyniam Global, Inc. is recalling 54 units of the Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004. The recall covers devices distributed nationwide in the United States. The recall is limited to specific case numbers and marketing materials up to revision A, as well as Instructions for Use (IFU) up to revision C.
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 the use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004
- Manufacturer
- Kelyniam Global, Inc.
- Category
- Medical Device — Implant
- Affected units
- 54
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