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Kelyniam CSI

KELYNIAM GLOBAL, INC. · Model PEEK-IM1004 · UDI-DI 00817580020249

GXN Prescription
1
510(k) clearances
824
Adverse events (2 deaths)
11
Recalls
49
Facilities

Description

PEEK Customized Cranial Implant, X-Large

Recalls

DateFirmReason
2018-08-22Zimmer Biomet, Inc.Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2018-08-22Zimmer Biomet, Inc.Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2018-08-22Zimmer Biomet, Inc.Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2018-08-22Zimmer Biomet, Inc.Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2018-08-22Zimmer Biomet, Inc.Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2018-08-22Zimmer Biomet, Inc.Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2017-06-10Kelyniam Global, Inc.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
2017-06-10Kelyniam Global, Inc.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
2017-06-10Kelyniam Global, Inc.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
2017-06-10Kelyniam Global, Inc.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

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.