Class II — Cardinal Health 200, LLC
| Recalling firm | Cardinal Health 200, LLC |
|---|---|
| Registered facility | View this company's 35 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential risk associated with corrosion demonstrated on the distraction screw surface. |
| Product | V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX. |
| Quantity | 72,076 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Germany, New Zealand, Saudi Arabia, South Africa, Switzerland and Thailand. |
| Initiated | 2016-09-23 |
| Classified | 2016-10-11 |
| Terminated | 2019-05-10 |
| Recall number | Z-0069-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cardinal Health 200, LLC (Z-0069-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75297/
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