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PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

Kontour(Xi'An) Medical Technology Co.,Ltd. · Model KT-T4L12H2 · UDI-DI 06903195108398

GXN

510(k) clearances

824

Adverse events (2 deaths)

Recalls

Facilities

Recalls

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