Recall Z-1870-2018— Kelyniam Global, Inc.
Class II · Terminated
Class II FDA medical device recall by Kelyniam Global, Inc., initiated 2017-06-10, terminated 2020-09-14. It names one FDA 510(k) clearance: K103582. Product: Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small). 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.
- Recalling firm
- Kelyniam Global, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-10
- Terminated
- 2020-09-14
- Firm location
- Collinsville, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.