DePuy Spine Recalls
36 recalls on record · January 23, 2013 to July 13, 2022 · Medical Devices
Recalls by year
13
15
16
18
19
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 13, 2022Medical DevicesFDA
DePuy Spine, Inc. recalls EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an
Hazard: 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
July 13, 2022Medical DevicesFDA
DePuy Spine, Inc. recalls EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an
Hazard: 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
May 8, 2019Medical DevicesFDA
DePuy Spine, Inc. recalls Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23
Hazard: A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
May 8, 2019Medical DevicesFDA
DePuy Spine, Inc. recalls Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (19
Hazard: A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants.
April 11, 2018Medical DevicesFDA
DePuy Spine, Inc. recalls Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)1
Hazard: 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.
November 30, 2016Medical DevicesFDA
DePuy Spine, Inc. recalls DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item Code: 186864018 The
Hazard: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
November 30, 2016Medical DevicesFDA
DePuy Spine, Inc. recalls DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 Th
Hazard: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
November 30, 2016Medical DevicesFDA
DePuy Spine, Inc. recalls DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: 186854018 The SKY
Hazard: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
November 30, 2016Medical DevicesFDA
DePuy Spine, Inc. recalls DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The
Hazard: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
November 30, 2016Medical DevicesFDA
DePuy Spine, Inc. recalls DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 The S
Hazard: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
November 30, 2016Medical DevicesFDA
DePuy Spine, Inc. recalls DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186852018 Th
Hazard: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
November 30, 2016Medical DevicesFDA
DePuy Spine, Inc. recalls DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186850018 T
Hazard: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.
December 30, 2015Medical DevicesFDA
DePuy Spine, Inc. recalls Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate Sys
Hazard: 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
June 3, 2015Medical DevicesFDA
DePuy Spine, Inc. recalls EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER
Hazard: Device does not mate as intended.
November 6, 2013Medical DevicesFDA
DePuy Spine, Inc. recalls PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilatio
Hazard: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
November 6, 2013Medical DevicesFDA
DePuy Spine, Inc. recalls PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for s
Hazard: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
November 6, 2013Medical DevicesFDA
DePuy Spine, Inc. recalls PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for se
Hazard: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
November 6, 2013Medical DevicesFDA
DePuy Spine, Inc. recalls PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for s
Hazard: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
November 6, 2013Medical DevicesFDA
DePuy Spine, Inc. recalls PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequ
Hazard: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared.
September 11, 2013Medical DevicesFDA
DePuy Spine, Inc. recalls CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for
Hazard: 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.
September 11, 2013Medical DevicesFDA
DePuy Spine, Inc. recalls CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Spinal Cement System is inte
Hazard: 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.
September 11, 2013Medical DevicesFDA
DePuy Spine, Inc. recalls CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended fo
Hazard: 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.
March 27, 2013Medical DevicesFDA
DePuy Spine, Inc. recalls DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is
Hazard: Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
March 27, 2013Medical DevicesFDA
DePuy Spine, Inc. recalls DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement,
Hazard: Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
March 27, 2013Medical DevicesFDA
DePuy Spine, Inc. recalls DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which
Hazard: Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
March 27, 2013Medical DevicesFDA
DePuy Spine, Inc. recalls DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which
Hazard: Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
January 30, 2013Medical DevicesFDA
DePuy Spine, Inc. recalls DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.
Hazard: 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.
January 30, 2013Medical DevicesFDA
DePuy Spine, Inc. recalls DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.
Hazard: 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
January 30, 2013Medical DevicesFDA
DePuy Spine, Inc. recalls DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant Component.
Hazard: 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
January 30, 2013Medical DevicesFDA
DePuy Spine, Inc. recalls DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component.
Hazard: 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