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Spinal Elements Recalls
24 recalls on record · May 15, 2013 to May 30, 2018 · Medical Devices
Recalls by year
13
15
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 30, 2018Medical DevicesFDA
Spinal Elements recalls AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lum
Hazard: Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
May 20, 2015Medical DevicesFDA
Spinal Elements, Inc recalls Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of sc
Hazard: Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marking interrupts the ability to maintain traceability of the device.
January 14, 2015Medical DevicesFDA
Spinal Elements, Inc recalls Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous
Hazard: Spinal Elements is recalling the Ti-Bond related brochures that includes LT-10000 and MP-14000 (all revisions) the content regarding the Ti-Bond coating within the literature is unsubstantiated in context and/or misleading for the coating's use in spine applications.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and s
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide immobilization and s
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and s
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to provide immobilization and s
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide immobilization and st
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and st
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. Intended to provide immobilization and st
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to provide immobilization and st
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to provide immobilization and st
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and st
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. Intended to provide immobilization and st
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. Intended to provide immobilization and s
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. Intended to provide immobilization and s
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. Intended to provide immobilization and s
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. Intended to provide immobilization and s
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. Intended to provide immobilization and s
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide immobilization and s
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. Intended to provide immobilization and s
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. Intended to provide immobilization and s
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040. Intended to provide immobilization and
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
May 15, 2013Medical DevicesFDA
Spinal Elements, Inc recalls Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and
Hazard: Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.