Depuy Spine recalls
Depuy Spine appears in 36 official U.S. recall notices indexed by RecallRadar, most recently on 2022-07-13.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 36 |
|---|---|
| Published | 2013-01-23 to 2022-07-13 |
| By agency | FDA Device (36) |
| By classification | Class II (36) |
| By status | terminated (34), ongoing (2) |
| Distribution named in notices | AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, US, VA, WA, WV, WY |
Recalls
- EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion i…
FDA Device · Class II · 2022-07-13 · Depuy Spine
Reason: 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 - EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion i…
FDA Device · Class II · 2022-07-13 · Depuy Spine
Reason: 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 - Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x2…
FDA Device · Class II · 2019-05-08 · Depuy Spine
Reason: A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants. - Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (1…
FDA Device · Class II · 2019-05-08 · Depuy Spine
Reason: A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants. - Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The…
FDA Device · Class II · 2018-04-11 · Depuy Spine
Reason: 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. - DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The SKYLINE¿ Anterior Cervic…
FDA Device · Class II · 2016-11-30 · Depuy Spine
Reason: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. - DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: 186854018 The SKYLINE¿ Anterior Cervical…
FDA Device · Class II · 2016-11-30 · Depuy Spine
Reason: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. - DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186850018 The SKYLINE¿ Anterior Cerv…
FDA Device · Class II · 2016-11-30 · Depuy Spine
Reason: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. - DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 The SKYLINE¿ Anterior Cervi…
FDA Device · Class II · 2016-11-30 · Depuy Spine
Reason: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. - DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 The SKYLINE¿ Anterior Cervic…
FDA Device · Class II · 2016-11-30 · Depuy Spine
Reason: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. - DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186852018 The SKYLINE¿ Anterior Cervi…
FDA Device · Class II · 2016-11-30 · Depuy Spine
Reason: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. - DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item Code: 186864018 The SKYLINE¿ Anterior Cervic…
FDA Device · Class II · 2016-11-30 · Depuy Spine
Reason: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. - Aegis Torque Handle CATALOG NO. : 2871-10-800
FDA Device · Class II · 2015-12-30 · Depuy Spine
Reason: 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 - EXPEDIUM Spine System/Synapse System
FDA Device · Class II · 2015-06-03 · Depuy Spine
Reason: Device does not mate as intended. - PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of…
FDA Device · Class II · 2013-11-06 · Depuy Spine
Reason: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. - PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of sof…
FDA Device · Class II · 2013-11-06 · Depuy Spine
Reason: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. - PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of s…
FDA Device · Class II · 2013-11-06 · Depuy Spine
Reason: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. - PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and e…
FDA Device · Class II · 2013-11-06 · Depuy Spine
Reason: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. - PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of…
FDA Device · Class II · 2013-11-06 · Depuy Spine
Reason: Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. - CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Spinal Cement System is intended for percutaneous d…
FDA Device · Class II · 2013-09-11 · Depuy Spine
Reason: 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. - CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous deliver…
FDA Device · Class II · 2013-09-11 · Depuy Spine
Reason: 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. - CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of…
FDA Device · Class II · 2013-09-11 · Depuy Spine
Reason: 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. - DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000
FDA Device · Class II · 2013-03-27 · Depuy Spine
Reason: Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck - DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000
FDA Device · Class II · 2013-03-27 · Depuy Spine
Reason: Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck - DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000
FDA Device · Class II · 2013-03-27 · Depuy Spine
Reason: Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck - DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000
FDA Device · Class II · 2013-03-27 · Depuy Spine
Reason: Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck - DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component
FDA Device · Class II · 2013-01-30 · Depuy Spine
Reason: 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 - DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant Component
FDA Device · Class II · 2013-01-30 · Depuy Spine
Reason: 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 - DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component
FDA Device · Class II · 2013-01-30 · Depuy Spine
Reason: 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 - DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component
FDA Device · Class II · 2013-01-30 · Depuy Spine
Reason: 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 - DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component
FDA Device · Class II · 2013-01-30 · Depuy Spine
Reason: 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 - DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component
FDA Device · Class II · 2013-01-30 · Depuy Spine
Reason: 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 - DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component
FDA Device · Class II · 2013-01-30 · Depuy Spine
Reason: 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. - DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component
FDA Device · Class II · 2013-01-30 · Depuy Spine
Reason: 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 - DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component
FDA Device · Class II · 2013-01-30 · Depuy Spine
Reason: 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 - DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expediu…
FDA Device · Class II · 2013-01-23 · Depuy Spine
Reason: 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.