RegWardenFDA facility compliance records
Facility

SPINAL ELEMENTS, INC.

4 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2009: 1 recalls; 2014: 1 recalls; 2015: 1 recalls; 2017: 1 inspections; 2018: 1 recalls; 2019: 1 inspections1’09’10’11’12’131’141’15’161’171’181’19’20’21’22’23’24’25’26
  • Recalls (4)
  • Inspections (2)

Devices registered here (1)

  • Intervertebral Fusion Device With Integrated Fixation, Cervical
    Product code OVE (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3080

Recalls & enforcement

  • Class IIOngoing2018-04-16
    Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis.
  • Class IIITerminated2015-04-09
    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 tr…
  • Class IITerminated2014-12-18
    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.
  • Class IIITerminated2009-04-17
    Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

FDA inspections (2)

  • NAI2019-05-14
    No Action Indicated · Compliance: Devices
  • VAI2017-09-29
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SPINAL ELEMENTS, INC. (FEI 3004893332) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004893332-spinal-elements-inc/

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