Device recall: Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
Kelyniam Global, Inc. (Collinsville, CT) initiated this device recall on 10 Jun 2017; FDA lists 4 product records under event 79791, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 14 Sep 2020. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Kelyniam Global, Inc..
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Kelyniam Global, Inc., Collinsville, CT.
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"
Distribution
"US nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1870-2018 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small) | 2 | Class II | Terminated | 23 May 2018 |
| Z-1871-2018 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002 | 16 | Class II | Terminated | 23 May 2018 |
| Z-1872-2018 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003 | 23 | Class II | Terminated | 23 May 2018 |
| Z-1873-2018 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004 | 54 | Class II | Terminated | 23 May 2018 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Sep 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.