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CD Horizon™ Astute™ Spinal System
MEDTRONIC SOFAMOR DANEK, INC. · Model 1608451125 · UDI-DI 00763000313111
1
510(k) clearances
848
Adverse events
50
Recalls
44
Facilities
Description
PEEK ROD 1608451125 6.0X6.9MM STR 125MM
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 |
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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.