Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 23, 2018
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
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…
Kelyniam Global, Inc. recalled Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small) - a moderate-severity action.
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small) was recalled by Kelyniam Global, Inc. in May 23, 2018. Reason: Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief h…. Check the official notice for the remedy. Verify recall #Z-1870-2018 with the FDA Devices before acting.
The recall
Kelyniam Global, Inc. issued this moderate-severity FDA Devices recall-Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief h….
- Moderate
- severity level
- 2 units
- affected scope
- Class II
- classification
- May 23, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1870-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1870-2018) was formally reported on May 23, 2018, with the manufacturer initiating the action on June 10, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Kelyniam Global, Inc. is listed as the recalling firm, operating out of Collinsville, CT. Federal records list the affected scope as 2.
The documented reason for this recall is: 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 validate… Distribution data in the federal record shows the product reached: US nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2
Related Recalls
6
6 from same agency
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1870-2018 |
| Date reported | May 23, 2018 |
| Date initiated | June 10, 2017 |
| Recalling firm | Kelyniam Global, Inc. |
| Firm location | Collinsville, CT |
| Affected scope | 2 |
| Distribution | US nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1870-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small). Recalled by Kelyniam Global, Inc.. Units affected: 2.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 23, 2018. Severity: Moderate. Recall number: Z-1870-2018.
Where was the recalled product distributed? ▼
Distribution: US nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1870-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nationwide recalls with similar severity or category timing
Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 23, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.