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aap Implantate AG · Model IS 1703-24 · UDI-DI 04042409453045

GFC Prescription
2
510(k) clearances
101
Adverse events
2
Recalls
87
Facilities

Description

Cleaning wire Ø2.2, L 255

Recalls

DateFirmReason
2014-09-09Zimmer, Inc.The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver.
2013-05-30Exactech, Inc.When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of the instrument.

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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.