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LEVEL ONE NEURO

KLS-Martin L.P. · Model 50-310-21-09 · UDI-DI 00888118074652

JEY Prescription

510(k) clearances

10,487

Adverse events (21 deaths)

111

Recalls

105

Facilities

Description

BURR HOLE COVER, LOW PROFILE, 3.2 MM DRAIN, CONTOURED, NEURO SCREW, CP TITANIUM

Recalls

Date	Firm	Reason
2023-06-19	Materialise N.V.	Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request
2020-11-25	Biomet, Inc.	Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
2020-06-18	Synthes, Inc.	One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clo
2020-06-16	Synthes Produktions GmbH	One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with
2020-02-03	Materialise N.V.	Custom surgical kits contain a plate different than indicated by the package labeling.
2020-02-03	Materialise N.V.	Custom surgical kits contain a plate different than indicated by the package labeling.
2018-04-05	Zimmer Biomet, Inc.	The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-con
2016-05-02	Synthes (USA) Products LLC	Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
2016-05-02	Synthes (USA) Products LLC	Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.
2016-05-02	Synthes (USA) Products LLC	Labeling errors. The outer packge label expiration date may exceed the expiration date of the subcomponents.

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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.