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CD HORIZON® SOLERA® Spinal System
MEDTRONIC SOFAMOR DANEK, INC. · Model 654100160 · UDI-DI 00643169749900
1
510(k) clearances
50,267
Adverse events (7 deaths)
101
Recalls
385
Facilities
Description
ROD 654100160 5.5 TI AL PERC ROD 160MM S
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-09-19 | Encore Medical, Lp | Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bi |
| 2017-09-29 | The Anspach Effort, Inc. | This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account. |
| 2017-05-22 | Zimmer Biomet, Inc. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa |
| 2017-05-22 | Zimmer Biomet, Inc. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa |
| 2017-05-22 | Zimmer Biomet, Inc. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa |
| 2017-05-22 | Zimmer Biomet, Inc. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa |
| 2017-05-22 | Zimmer Biomet, Inc. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa |
| 2017-05-22 | Zimmer Biomet, Inc. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa |
| 2017-05-22 | Zimmer Biomet, Inc. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa |
| 2017-05-22 | Zimmer Biomet, Inc. | Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increa |
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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.