DePuy Spine, Inc.

FDA Regulatory Profile

Summary

Total Recalls
36
510(k) Clearances
71
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1324-2022Class IIEIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autogrMay 20, 2022
Z-1323-2022Class IIEIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autogrMay 20, 2022
Z-1226-2019Class IIConcorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (April 8, 2019
Z-1225-2019Class IIConcorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (19April 8, 2019
Z-1300-2018Class IIConfidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 28December 15, 2017
Z-0624-2017Class IIDePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item COctober 12, 2016
Z-0625-2017Class IIDePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item CoOctober 12, 2016
Z-0629-2017Class IIDePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item CoOctober 12, 2016
Z-0626-2017Class IIDePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item CodeOctober 12, 2016
Z-0630-2017Class IIDePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item CodeOctober 12, 2016
Z-0628-2017Class IIDePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: October 12, 2016
Z-0627-2017Class IIDePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item CodOctober 12, 2016
Z-0454-2016Class IIAegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS AnterNovember 20, 2015
Z-1674-2015Class IIEXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 175April 21, 2015
Z-0094-2014Class IIPIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding CliJuly 31, 2013
Z-0093-2014Class IIPIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip aJuly 31, 2013
Z-0095-2014Class IIPIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding ClipJuly 31, 2013
Z-0096-2014Class IIPIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding CliJuly 31, 2013
Z-0097-2014Class IIPIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended foJuly 31, 2013
Z-2132-2013Class IICONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement SApril 17, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K222276CONDUIT Cages; FIBERGRAFT BG PuttyOctober 15, 2022
K201831CONFIDENCE Spinal Cement SystemAugust 31, 2020
K142185EXPEDIUM VERSE SPINE SYSTEMNovember 19, 2014
K111136EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEMJune 14, 2012
K121020VIPER SYSTEMMay 3, 2012
K110353MOUNTAINEER OCT SPINAL SYSTEMApril 7, 2011
K110216EXPEDIUM SYSTEM, VIPER SYSTEMApril 1, 2011
K103133VEPER SYSTEM, EXPEDIUM SYSTEMJanuary 18, 2011
K101993VIPER SYSTEM, EXPEDIUM SYSTEMDecember 7, 2010
K101923CONCORDE CURVE SYSTEMDecember 1, 2010
K103100MOUNTAINEER OCT SPINAL SYSTEMNovember 17, 2010
K101762VIPER F2 FACET FIXATION SYSTEMNovember 15, 2010
K102701VIPER SPINE SYSTEMOctober 20, 2010
K101933MODIFICATION TO:EXPEDIUM SPINE SYSTEMOctober 18, 2010
K093390HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025May 25, 2010
K100070UNIPLATE ANTERIOR CERVICAL PLATE SYSTEMFebruary 4, 2010
K091994MOUNTAINEER LAMINOPLASTY SYSTEMJanuary 7, 2010
K092473EXPEDIUM SPINE SYSTEMNovember 25, 2009
K092626MODIFICATION TO: EXPEDIUM SPINE SYSTEMSeptember 25, 2009
K090648VIPER 2 SYSTEMJune 10, 2009