Spinal Elements recalls

Spinal Elements has 24 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 30 May 2018. 1 is still ongoing. The most frequent reason is lead & heavy metals.

Total recalls24since 2013

Last 12 months0reported

Class I00% of total

Ongoing1latest 30 May 2018

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 8%Class III 22 92%

Why spinal elements is recalled

Lead & Heavy Metals2292%
Other Reasons28%

Product types

Spinal Implants2396%
Other Medical Devices14%

By year

201814%
201528%
20132188%

Ongoing spinal elements recalls

1 active

Reported	Class	Recall	Company	Reason	Where
30 May 2018Device	CLASS II	Amendia Omega Lumbar Interbody Fusion Device recalled by Spinal Elements	Spinal Elements	Other	5 states

All spinal elements recalls, newest first

24 total

Reported	Class	Recall	Company	Reason	Where
30 May 2018Device	CLASS II	Amendia Omega Lumbar Interbody Fusion Device recalled by Spinal Elements	Spinal Elements	Other	5 states
20 May 2015Device	CLASS III	5 Mercury lordosed rod recalled by Spinal Elements	Spinal Elements	Lead & Heavy Metals	Nationwide
14 Jan 2015Device	CLASS II	Ti-Bond Marketing Literature/Labeling recalled by Spinal Elements	Spinal Elements	Other	Nationwide
15 May 2013Device	CLASS III	Mercury Spinal System DIA 5 Straight Rod recalled by Spinal Elements	Spinal Elements	Lead & Heavy Metals	OH, PA
15 May 2013Device	CLASS III	Mercury Spinal System DIA MM Lordosed Rod recalled by Spinal Elements	Spinal Elements	Lead & Heavy Metals	OH, PA
15 May 2013Device	CLASS III	Mercury Spinal System DIA MM Lordosed Rod recalled by Spinal Elements	Spinal Elements	Lead & Heavy Metals	OH, PA
15 May 2013Device	CLASS III	Mercury Spinal System DIA 5 Lordosed Rod recalled by Spinal Elements	Spinal Elements	Lead & Heavy Metals	OH, PA
15 May 2013Device	CLASS III	Mercury Spinal System DIA MM Lordosed Rod recalled by Spinal Elements	Spinal Elements	Lead & Heavy Metals	OH, PA
15 May 2013Device	CLASS III	Mercury Spinal System DIA 5 Straight Rod recalled by Spinal Elements	Spinal Elements	Lead & Heavy Metals	OH, PA
15 May 2013Device	CLASS III	Mercury Spinal System DIA MM Lordosed Rod recalled by Spinal Elements	Spinal Elements	Lead & Heavy Metals	OH, PA

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.