CLASS II Device recall · Reported 19 Oct 2016 · FDA Enforcement Report
V. Mueller Neuro/Spine, Shadow-line recalled by Cardinal Health 200
Cardinal Health 200 is recalling V. Mueller Neuro/Spine, Shadow-line, Spinal Distraction Screw, Sterile, various sizes and, distributed nationwide in the US. The recall was initiated on 23 Sep 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0069-2017
- FDA event ID
- 75297
- Recalling firm
- Cardinal Health 200, Waukegan, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Sep 2016
- FDA classified
- 11 Oct 2016
- Reported
- 19 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 23 Sep 2016 | Recall initiated by company | |
| 11 Oct 2016 | Classified by FDA | +18 days |
| 19 Oct 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential risk associated with corrosion demonstrated on the distraction screw surface.
Product as listed by the FDA
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
Where it was distributed
Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Germany, New Zealand, Saudi Arabia, South Africa, Switzerland and Thailand.
Questions about this recall
Why was it recalled?
Potential risk associated with corrosion demonstrated on the distraction screw surface.
Which lots are affected?
12 MM Screw Distraction with Product Code: S-0088 and etched with Manufacturing lot number and date: G11 07/25/2011, J11 10/27/2011, D12 04/24/2012, D12 04/24/2012, F12 06/06/2012, K12 11/06/2012, K12 11/06/2012, L12 12/12/2012, F13 06/20/2013, H13 08/26/2013, I13 09/04/2013, J13 10/29/2013, J13 10/29/2013, A14 01/03/2014, A14 01/22/2014, C14 03/06/2014, D14 04/24/2014, G14 07/31/2014, I14 09/03/2014, L14 12/16/2014, D15 04/01/2015, D15 04/01/2015, F15 06/04/2015, H15 08/11 /2015, I15 09/23/2015, K15 11/18/2015, A16 01/06/2016, B16 02/15/2016, C16 03/08/2016, D16 04/21/2016, E16 05/18/2016 and F16 06/14/2016. Contained in sterile packages with the following packaging lot numbers and date: 979662 01/07/2011, 985463 03/08/2011, 009375 06/23/2011, 043419 10/21/2011, 064776 02/03/2012, 102167 09/11/2012, 110798 09/25/2012, 127811 12/11/2012, 859648 01/09/2014, 859649 01/09/2014, 859650 01/09/2014, 859651 01/09/2014, 862414 04/23/2014, 862415 04/23/2014, 862416 04/23/2014, 862417 04/23/2014, 862418 04/23/2014, 862419 04/23/2014, 862420 04/23/2014, 868984 02/16/2015, 868985 02/16/2015, 868986 02/16/2015, 873620 08/11/2015, 873621 08/11/2015, 873622 08/11/2015, 873623 08/11/2015, 876504 12/14/2015, 876505 12/14/2015, 876506 12/14/2015, 879271 04/04/2016, 879272 04/04/2016, 881178 06/10/2016, 881179 06/10/2016 and 881180 06/10/2016. 14MM Screw Distraction with Product Code: S-0089 and etched with Manufacturing lot number and date: E11 05/25/2011, G11 07/28/2011, J11 10/27/2011, C12 03/27/2012, F12 06/12/2012, G12 07/26/2012, I12 09/19/2012, I12 09/19/2012, J12 10/09/2012, J12 10/31/2012, L12 12/03/2012, L12 12/07/2012, A13 01/08/2013, G13 07/19/2013, I13 09/04/2013, J13 10/29/2013, J13 10/29/2013, A14 01/03/2014, A14 01 /22/2014, 014 04/24/2014 I, F14 06/16/2014, F14 06/16/2014, C14 03/06/2014, G14 07/24/2014, I14 09/03/2014, J14 10/17/2014, L14 12/1 6/2014, D15 04/01/2015, D15 04/01/2015, F15 06/04/2015, F15 06/02/2015, G15 07/16/2015, I15 09/15/2015, K15 11/18/2015, A16 01/06/2016, 816 02/15/2016, B16 02/15/2016, C16 03/08/2016 and D16 04/21/2016. Contained in sterile packages with the following packaging lot numbers and date: 009413 06/22/2011, 038155 10/11/2011, 064187 02/03/2012, 098560 07/12/2012, 100104 07/24/2012, 127814 12/11/2012, 859626 01/09/2014, 859627 01/09/2014, 859645 01/09/2014, 859646 01/09/2014, 859647 01/09/2014, 862172 04/23/2014, 862173 04/23/2014, 862174 04/23/2014, 862194 04/23/2014, 862195 04/23/2014, 862196 04/23/2014, 862197 04/23/2014, 862198 04/23/2014, 862199 04/23/2014, 865271 09/23/2014, 865300 09/23/2014, 865301 09/23/2014, 865302 09/23/2014, 865303 09/23/2014, 865351 09/23/2014, 868947 02/16/2015, 868948 02/16/2015, 868949 02/16/2015, 868950 02/16/2015, 872970 08/05/2015, 872971 08/05/2015, 872972 08/05/2015, 872973 08/05/2015, 873669 08/11/2015, 873670 08/11/2015, 873671 08/11/2015, 876472 12/14/2015, 876473 12/14/2015, 876474 12/14/2015 I, 879298 04/04/2016, 879299 04/04/2016, 881174 06/10/2016, 881175 06/10/2016, 881176 06/10/2016, 881177 06/10/2016 and 985679 03/08/2011. 16 MM Screw Distraction with Product Code: S-0090 and etched with Manufacturing lot number and date: Al2 1/20/2012, C12 3/27/2012, A13 1/10/2013, J13 10/3/2013 and G14 7/24/2014. Contained in sterile packages with the following packaging lot numbers and date: 003923 05/12/2011, 098394 07/13/2012, 854634 04/1 9/2013, 854635 04/1 9/2013, 854636 04/19/2013 and 862500 04/23/2013. 18 MM Screw Distraction with Product Code: S-009 and etched with Manufacturing lot number and date: A12 1/16/2012 and F12 6/12/2012. Contained in sterile packages with the following packaging lot numbers and date: 120328 10/9/2012, 133021 12/20/2012 and 133021 12/20/2012.
Where was it sold?
Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Germany, New Zealand, Saudi Arabia, South Africa, Switzerland and Thailand.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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