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ClearFit

LONGEVITI NEURO SOLUTIONS LLC · Model 171714 · UDI-DI 00855113008043

GXN PJN

510(k) clearances

827

Adverse events (2 deaths)

Recalls

Facilities

Description

Complex Static Cranial Implant (Primary and Backup)

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.