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Medicon

Medicon eG. Chirurgiemechaniker-Genossenschaft · Model 68.78.17A · UDI-DI 04046826343477

JEY Prescription

510(k) clearances

10,393

Adverse events (21 deaths)

111

Recalls

105

Facilities

Description

Ti Mini Star Grip screw 2.0x17mm grey self-tapp p/10

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.