Reported Oct 19, 2016 · Terminated
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER…
Cardinal Health 200, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health 200, LLC · 1500 S Waukegan Rd · Waukegan, IL · 60085-6728
Is this the product you have?
- V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
- Lot codes and dates
- 12
- MM Screw Distraction with Product CodeS-0088 and etched
- with Manufacturing lot number and dateG11 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 date979662 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 CodeS-0089 and etched
- with Manufacturing lot number and dateE11 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 06/22/2011038155 10/11/2011064187 02/03/2012098560 07/12/2012100104 07/24/2012127814 12/11/2012859626 01/09/2014859627 01/09/2014859645 01/09/2014859646 01/09/2014859647 01/09/2014862172 04/23/2014862173 04/23/2014862174 04/23/2014862194 04/23/2014862195 04/23/2014862196 04/23/2014862197 04/23/2014862198 04/23/2014862199 04/23/2014865271 09/23/2014865300 09/23/2014865301 09/23/2014865302 09/23/2014865303 09/23/2014865351 09/23/2014868947 02/16/2015868948 02/16/2015868949 02/16/2015868950 02/16/2015872970 08/05/2015872971 08/05/2015872972 08/05/2015872973 08/05/2015873669 08/11/2015873670 08/11/2015873671 08/11/2015876472 12/14/2015876473 12/14/2015876474 12/14/2015 I879298 04/04/2016879299 04/04/2016881174 06/10/2016881175 06/10/2016881176 06/10/2016881177 06/10/2016 and 985679 03/08/2011. 16
- MM Screw Distraction with Product CodeS-0090 and etched
- with Manufacturing lot number and dateAl2 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 05/12/2011098394 07/13/2012854634 04/1 9/2013854635 04/1 9/2013854636 04/19/2013 and 862500 04/23/2013. 18
- MM Screw Distraction with Product CodeS-009 and etched
- with Manufacturing lot number and dateA12 1/16/2012 and F12 6/12/2012. Contained in sterile packages with the following
- packaging lot numbers and date
120328 10/9/2012133021 12/20/2012 and 133021 12/20/2012
- Amount recalled
- 72,076 units
Where it was sold
- Nationwide
Why it was recalled
Potential risk associated with corrosion demonstrated on the distraction screw surface.
This product could cause temporary or reversible health problems — stop using it.
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