Home › MEDTRONIC SOFAMOR DANEK, INC. › CD HORIZON® ASTUTE™ SPINAL SYSTEM
CD HORIZON® ASTUTE™ SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK, INC. · Model 1608451070 · UDI-DI 00643169281165
1
510(k) clearances
848
Adverse events
50
Recalls
44
Facilities
Description
PEEK ROD 1608451070 6.0 X 6.9MM STR 70MM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-09-04 | Zimmer, Inc. | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiv |
| 2012-09-04 | Zimmer, Inc. | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiv |
| 2012-09-04 | Zimmer, Inc. | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiv |
| 2012-09-04 | Zimmer, Inc. | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiv |
| 2012-09-04 | Zimmer, Inc. | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiv |
| 2012-09-04 | Zimmer, Inc. | Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthru, Switzerland, after receiv |
| 2009-05-28 | Zimmer Inc. | The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay. |
| 2009-02-09 | Synthes USA (HQ), Inc. | package integrity compromised |
| 2009-02-09 | Synthes USA (HQ), Inc. | package integrity compromised |
| 2009-02-09 | Synthes USA (HQ), Inc. | package integrity compromised |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.