Manufacturer

DePuy Spine, Inc.

36 recalls in our database name DePuy Spine, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 36
Critical: 0
Severe: 10
Most recent: 2022-07-13

Of the 36 recalls from DePuy Spine, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (28%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 36

ModerateFDA (Devices)·Z-1323-2022·2022-07-13
EIT CIF Cage Intervertebral Fusion Device Carton Labeling Mismatch Recall
DePuy Spine is recalling 61 units of the EIT CIF cage spinal fusion device due to a labeling mismatch. The outer carton label does not match the labels on the blister packages and patient information labels.
Product
EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD). Part Number: CUI8060L
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1324-2022·2022-07-13
Intervertebral fusion device recalled for outer carton labeling discrepancy
DePuy Spine's EIT CIF intervertebral fusion cage (46 units, Part No. CUI8070S) is recalled due to a labeling discrepancy where the outer carton label does not match the labels on the product packaging and patient materials.
Product
EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) Part Number: CUI8070S
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1226-2019·2019-05-08
DePuy Spine Recalls Concorde Lift Spinal Fusion Implants Due to Migration
DePuy Spine is recalling Concorde Lift spinal fusion implants because a complaint trend was observed for post-operative loss of height and migration.
Product
Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1225-2019·2019-05-08
DePuy Spine Recalls Concorde Lift Spinal Fusion Implants
DePuy Spine is recalling Concorde Lift spinal fusion implants due to a complaint trend of post-operative loss of height and migration.
Product
Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1300-2018·2018-04-11
DePuy Spine Recalls Confidence Plus Kit Spinal Cement System Lots
DePuy Spine is recalling specific lots of the Confidence Plus Kit Spinal Cement System because they may contain incorrect amounts of contrast medium, making the product difficult or impossible to visualize on x-ray.
Product
Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for f
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0630-2017·2016-11-30
DePuy Spine Recalls SKYLINE Anterior Cervical Plate Screws
DePuy Spine is recalling 12 SKYLINE Anterior Cervical Plate System screws because they may have been packaged with the wrong screw type.
Product
DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm Item Code: 186864018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic or
Category
Medical Device
Distribution
15 states
ModerateFDA (Devices)·Z-0625-2017·2016-11-30
DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws
DePuy Spine is recalling 14 units of SKYLINE Variable Self-Drilling Screws because they may have been packaged with Constrained Ti screws.
Product
DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186852018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic o
Category
Medical Device
Distribution
15 states
ModerateFDA (Devices)·Z-0626-2017·2016-11-30
DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws
DePuy Spine is recalling SKYLINE Variable Self-Tapping Screws because the packaging may contain Constrained Ti screws instead.
Product
DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm Item Code: 186852020 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic orig
Category
Medical Device
Distribution
15 states
ModerateFDA (Devices)·Z-0627-2017·2016-11-30
DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws
DePuy Spine is recalling SKYLINE Variable Self-Tapping Screws because the packaging may contain Constrained Ti screws instead.
Product
DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm Item Code: 186852026 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic ori
Category
Medical Device
Distribution
15 states
ModerateFDA (Devices)·Z-0628-2017·2016-11-30
DePuy Spine Recalls SKYLINE Anterior Cervical Plate Screws
DePuy Spine is recalling 9 units of SKYLINE Variable Oversized Screws because they may have been packaged with Constrained Ti screws.
Product
DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item Code: 186854018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin
Category
Medical Device
Distribution
15 states
ModerateFDA (Devices)·Z-0624-2017·2016-11-30
DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws
DePuy Spine is recalling 9 units of SKYLINE Variable Self-Drilling Screws because they may have been packaged with Constrained Ti screws.
Product
DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm Item Code: 186850018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic
Category
Medical Device
Distribution
15 states
ModerateFDA (Devices)·Z-0629-2017·2016-11-30
DePuy Spine Recalls SKYLINE Anterior Cervical Plate System Screws
DePuy Spine is recalling 21 units of SKYLINE Anterior Cervical Plate System Constrained Self-Tapping Screws because Variable Ti screws may have been incorrectly packaged with them.
Product
DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic o
Category
Medical Device
Distribution
15 states
ModerateFDA (Devices)·Z-0454-2016·2015-12-30
DePuy Spine Recalls Aegis Torque Handles Due to Assembly Defect
DePuy Spine is recalling 16 Aegis Torque Handles because a manufacturing error may prevent them from fully assembling with the tightener shaft.
Product
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System.
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1674-2015·2015-06-03
DePuy Spine Recalls EXPEDIUM Offset Conical Lock Nut Devices
DePuy Spine, Inc. is recalling 183 EXPEDIUM Offset Conical Lock Nut 8mm devices because they do not mate as intended.
Product
EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0095-2014·2013-11-06
DePuy Spine Recalls Pipeline LS Dilators for Uncleared Neuromonitoring Use
DePuy Spine is recalling 102 units of Pipeline LS Dilators and Holding Clips because they were used for neuromonitoring, a function for which the devices are not FDA cleared.
Product
PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0093-2014·2013-11-06
DePuy Spine Pipeline LS Dilator Recall for Uncleared Neuromonitoring Use
DePuy Spine is recalling 118 Pipeline LS Dilators and Holding Clips because they were used for neuromonitoring, a function for which the devices are not FDA cleared.
Product
PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0096-2014·2013-11-06
DePuy Spine Recalls Pipeline LS Dilators for Uncleared Neuromonitoring Use
DePuy Spine is recalling 100 units of Pipeline LS Dilators because they were used for neuromonitoring, a function for which the device is not FDA cleared.
Product
PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0097-2014·2013-11-06
DePuy Spine Recalls Pipeline LS Holding Clips for Uncleared Use
DePuy Spine is recalling 198 Pipeline LS Holding Clips because they were used for neuromonitoring, a function for which the device is not FDA cleared.
Product
PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0094-2014·2013-11-06
DePuy Spine Recalls Pipeline LS Dilators for Uncleared Neuromonitoring Use
DePuy Spine is recalling 105 Pipeline LS Access System dilators and holding clips because they were used for neuromonitoring, a function for which the devices are not cleared.
Product
PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2132-2013·2013-09-11
DePuy Spine Recalls Confidence Spinal Cement System 5cc Kits
DePuy Spine is recalling Confidence Spinal Cement System 5cc kits because hydraulic pump leaks can cause loss of pressure during injection.
Product
CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or ky
Category
Medical Device
Distribution
33 states
HighFDA (Devices)·Z-2134-2013·2013-09-11
DePuy Spine Recalls Confidence Spinal Cement System Kits
DePuy Spine is recalling Confidence Spinal Cement System Kits because hydraulic pump leaks can cause loss of pressure during cement injection.
Product
CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyph
Category
Medical Device
Distribution
33 states
ModerateFDA (Devices)·Z-2133-2013·2013-09-11
DePuy Spine Recalls Confidence Spinal Cement System Due to Pump Leak
DePuy Spine is recalling the Confidence Spinal Cement System 11CC Plus Kit because water leaks in the hydraulic pump cause pressure loss, preventing cement injection.
Product
CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplast
Category
Medical Device
Distribution
33 states
HighFDA (Devices)·Z-0963-2013·2013-03-27
DePuy Spine Recalls CONFIDENCE Spinal Cement System Kits
DePuy Spine is recalling CONFIDENCE Spinal Cement System Kits because the cement mixer may not turn properly and could jam or get stuck during surgery.
Product
DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0960-2013·2013-03-27
DePuy Confidence Spinal Cement Mixer Recall for Jamming Defect
DePuy Spine is recalling the Confidence Spinal Cement System 5cc Kit because the cement mixer may not turn properly and may jam or get stuck during surgery.
Product
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0962-2013·2013-03-27
DePuy Spine Recalls Cement Mixer Kits Due to Jamming Risk
DePuy Spine is recalling CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus kits because the cement mixer may jam or fail to turn properly during surgery.
Product
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
Category
Medical Device
Distribution
Distributed nationwide