Kelyniam Custom Skull Implant Recall: Unvalidated Design Changes Risk Injury
Kelyniam recalls Custom Skull Implant (CSI) Model PEEK-IM1003 with unvalidated design changes that may cause injury. Affected units include specific case numbers and revisions up to rev. A.
Recall notice
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
Contact the company
What happened, in plain English
Kelyniam is recalling Custom Skull Implant (CSI) Model PEEK-IM1003 due to unvalidated design changes that could lead to injury. This recall affects specific case numbers and revisions of the implant sold up to a certain date. Read more at govinfonow.com/recall/73887-kelyniam-custom-skull-implant-recall-unvalidated-design-changes-risk-injury.
Source Summary by GovInfoNow · govinfonow.com/recall/73887-kelyniam-custom-skull-implant-recall-unvalidated-design-changes-risk-injury · Updated September 23, 2026 · FDA enforcement record: FDA #Z-1872-2018
Cite this page
“Kelyniam Custom Skull Implant Recall: Unvalidated Design Changes Risk Injury.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73887-kelyniam-custom-skull-implant-recall-unvalidated-design-changes-risk-injury. Based on FDA recall #Z-1872-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1872-2018%22&limit=1).
Why it’s dangerous
The implant design changes, such as removing pressure relief holes and adding suture holes, were not validated or submitted to the FDA for marketing clearance. This means the changes could cause injury during use without proper safety testing.
Who’s affected
Patients who received the Kelyniam Custom Skull Implant (CSI) Model PEEK-IM1003 with case numbers listed in the recall are most at risk. Medical professionals using the implant for surgical procedures may also be affected.
How to tell if you have this one
Check if your implant has the model number PEEK-IM1003 and case numbers listed in the recall. The product was sold with revisions up to rev. A in the marketing materials and up to rev. C in the instructions.
- Brand
Kelyniam- Category
Medical device
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US nationwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1870-2018 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small); Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C. Case Numbers: CSI041216-CM1 CSI092016-LD1L | 2 |
| Z-1871-2018 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002; Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C. Case Numbers: CSI082114-CT1 CSI081214-TB1 CSI020216-LK1 CSI092016-LD1R CSI100116-BM1A CSI092616-YB1 CSI092616-MM1 CSI112316-YB1 CSI050217-LS1 CSI052217-AF1 CSI062317-GM1 CSI071017-NS1B CSI071417-CM1 CSI102617-DL1 CSI101617-JF1A CSI102617-DL1 | 16 |
| Z-1872-2018 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003; Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C. Case Numbers: CSI111715-KH1 CSI072814-JB1 CSI082514-MA1 CSI080714-CT1 CSI091914-JW1 CSI101614-TR1 CSI041415-MZ1 CSI100915-DD1 CSI120215-MM1 CSI100915-DD2 CSI011816-TA1 CSI012016-RT1A CSI012716-MP1 CSI021116-CA1 CSI030716-BC1 CSI040716-CK1 CSI060916-DF1 CSI070716-AC1 CSI092116-JA1 CSI110416-DW1 CSI120616-LS1 CSI012417-SD1 CSI062617-HR1 | 23 |
| Z-1873-2018 | Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1004; Marketing Material: All revisions up to rev. A. IFU: All revisions up to rev. C. Case Numbers: CSI070314-JF1 CSI082214-EC1 CSI090314-CG1 CSI091614-JB1 CSI101414-RA1 CSI110514-SS2 CSI120814-JC1 CSI121114-DD1 CSI121614-LG1 CSI121714-OL1 CSI011615-AC1 CSI012915-JG1 CSI012915-SS1 CSI022415-HL1 CSI040615-RA1 CSI060115-EB1 CSI102215-CT1 CSI112415-ES1 CSI101615-BE1 CSI012016-RT1B CSI022916-CS1 CSI032216-SP1 CSI020216-JR1 CSI051716-TM1 CSI070516-AT1 CSI070116-EG1 CSI072816-JE1 CSI092716-AV1 CSI101416-TY1 CSI110816-CS1 CSI112316-NK1 CSI092616-CB1 CSI111516-RB1 CSI113016-NR1 CSI111616-FH1 CSI010517-JH1 CSI041417-KK1 CSI060117-AR1 CSI062617-LV1 CSI071017-NS1A CSI081717-GG1 CSI081717-JM1 CSI082717-LH1 CSI082917-UK1 CSI081717-JM1 CSI090617-JH2 CSI092717-DH1 CSI092617-OT1 CSI100417-EZ1 CSI100517-AE1 CSI100617-MH1 CSI101817-KD1 CSI102617-NK1 CSI101617-JF1B | 54 |
What to do — step by step
Check Product Details
Review the model number and case numbers listed in the recall to confirm if your implant is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1872-2018 (June 10, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1872-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.