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COLUMBUS REVISION
Aesculap AG · Model NQ724RM · UDI-DI 04046963850302
HTZ
Prescription
10
510(k) clearances
1,496
Adverse events
27
Recalls
230
Facilities
Description
COLUMBUS REV 4-IN-1 FEM.CUTTING GUIDE F4
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-01-03 | DePuy Orthopaedics, Inc. | The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery. |
| 2015-07-01 | The Anspach Effort, Inc. | Saw head separated from the drive unit or began to come loose. |
| 2014-04-22 | Synthes, 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. |
| 2013-08-13 | Tornier, Inc | Following 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 |
| 2008-12-18 | Biomet, 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. |
| 2008-12-18 | Biomet, 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. |
| 2008-12-18 | Biomet, 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. |
| 2008-12-18 | Biomet, 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. |
| 2008-12-18 | Biomet, 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. |
| 2008-12-18 | Biomet, 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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Get your free API keyRead the docsData 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.