RegWardenFDA facility compliance records
Facility

DEPUY SPINE, INC.

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

Activity by year

FDA actions on record by year2012: 2 recalls; 2013: 3 recalls; 2015: 2 recalls; 2016: 1 recalls; 2017: 1 recalls, 1 inspections; 2019: 1 recalls, 1 inspections; 2022: 1 recalls2’123’13’142’151’162’17’182’19’20’211’22’23’24’25’26
  • Recalls (11)
  • Inspections (2)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2022-05-20
    Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton
  • Class IITerminated2019-04-08
    A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
  • Class IITerminated2017-12-15
    Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray.
  • Class IITerminated2016-10-12
    SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
  • Class IITerminated2015-11-20
    Manufacturing error within the Torque Handle may prohibit some handles from being able to fully assemble with the tightener shaft. The design of the inspection gage does not account for the additional shift length
  • Class IITerminated2015-04-21
    Device does not mate as intended.
  • Class IITerminated2013-07-31
    Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
  • Class IITerminated2013-04-17
    During injection of cement, the water in the hydraulic pump leaks past the piston within the pump body resulting in the loss of pressure and inability to continue to inject cement.
  • Class IITerminated2013-01-15
    Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
  • Class IITerminated2012-11-07
    Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head
  • Class IITerminated2012-07-24
    A component within the handle of the Expedium Offset Torque Wrench is prematurely wearing, potentially resulting in the instrument recording torque values outside of the specification.

FDA inspections (2)

  • NAI2019-04-18
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2017-06-16
    No Action Indicated · Compliance: Devices

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. “DEPUY SPINE, INC. (FEI 1526439) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1526439-depuy-spine-inc/

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