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IPS

KLS-Martin L.P. · Model 60-000-74-09 · UDI-DI 00888118100764

GXN Prescription
10
510(k) clearances
824
Adverse events (2 deaths)
11
Recalls
49
Facilities

Description

IMPLANT, MANDIBLE, CRIB MESH, 00074, 1.5 MM SCREW, TI-6AL-4V

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.