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COLUMBUS

Aesculap AG · Model NQ087R · UDI-DI 04046963436674

HTZ Prescription
10
510(k) clearances
1,496
Adverse events
27
Recalls
230
Facilities

Description

COLUMBUS 4-IN-1 FEMORAL CUTTING GUIDE L7

Recalls

DateFirmReason
2020-01-03DePuy Orthopaedics, Inc.The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
2015-07-01The Anspach Effort, Inc.Saw head separated from the drive unit or began to come loose.
2014-04-22Synthes, Inc.It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot.
2013-08-13Tornier, IncFollowing the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Frac
2008-12-18Biomet, Inc.Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
2008-12-18Biomet, Inc.Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
2008-12-18Biomet, Inc.Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
2008-12-18Biomet, Inc.Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
2008-12-18Biomet, Inc.The Falling component: universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
2008-12-18Biomet, Inc.Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.

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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.