Reported May 23, 2018 · Terminated
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
Kelyniam Global, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Kelyniam Global, Inc. · 97 River Rd · Collinsville, CT · 06019-3246
Is this the product you have?
- Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1001 (Small)
- Lot codes and dates
- Marketing MaterialAll revisions up to rev. A
- IFUAll revisions up to rev. C
- Case NumbersCSI041216-CM1 CSI092016-LD1L
- Amount recalled
- 2
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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