V — Class II medical device recall Z-0069-2017
Terminated recall by Cardinal Health 200, LLC, reported 2016-10-19, distributed nationwide. Potential risk associated with corrosion demonstrated on the distraction screw surface.
| Recall number | Z-0069-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2016-09-23 |
| Classified | 2016-10-11 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2019-05-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CH, DE, NZ, SA, TH, ZA |
| Quantity | 72,076 units |
| Lot numbers | 003923, 009375, 009413, 014I, 038155, 04/1, 043419, 064187, 064776, 08/11, 098394, 098560, 100104, 102167, 110798, 12/1, 120328, 127811, 127814, 133021, 14MM, 2015, 22/2014, 816, 854634, 854635, 854636, 859626, 859627, 859645, 859646, 859647, 859648, 859649, 859650, 859651, 862172, 862173, 862174, 862194 and 96 more |
Product
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
Reason for recall
Potential risk associated with corrosion demonstrated on the distraction screw surface.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0069-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.