DePuy Spine, Inc.
Complete recall history across all FDA and CPSC categories — 36 total recalls
DePuy Spine, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (36)
FDA medical device enforcement actions by DePuy Spine, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| May 20, 2022 | EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indica... | Label on the Outer Carton does not match the labels on the Outer Blister pack... | Class II |
| May 20, 2022 | EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indica... | Label on the Outer Carton does not match the labels on the Outer Blister pack... | Class II |
| Apr 8, 2019 | Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x... | A complaint trend was observed for post-operative loss of height and migratio... | Class II |
| Apr 8, 2019 | Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21... | A complaint trend was observed for post-operative loss of height and migratio... | Class II |
| Dec 15, 2017 | Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01... | Certain lots of the spinal cement may contain incorrect amounts of contrast m... | Class II |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCR... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws w... | Class II |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW ... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws w... | Class II |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCRE... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws w... | Class II |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SC... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws w... | Class II |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCRE... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws w... | Class II |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING ... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws w... | Class II |
| Oct 12, 2016 | DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCR... | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws w... | Class II |
| Nov 20, 2015 | Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument ... | Manufacturing error within the Torque Handle may prohibit some handles from b... | Class II |
| Apr 21, 2015 | EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut... | Device does not mate as intended. | Class II |
| Jul 31, 2013 | PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS D... | Dilators and Holding Clip are being used for a secondary function of neuromon... | Class II |
| Jul 31, 2013 | PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS D... | Dilators and Holding Clip are being used for a secondary function of neuromon... | Class II |
| Jul 31, 2013 | PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dila... | Dilators and Holding Clip are being used for a secondary function of neuromon... | Class II |
| Jul 31, 2013 | PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holdi... | Dilators and Holding Clip are being used for a secondary function of neuromon... | Class II |
| Jul 31, 2013 | PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Di... | Dilators and Holding Clip are being used for a secondary function of neuromon... | Class II |
| Apr 17, 2013 | CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 ... | During injection of cement, the water in the hydraulic pump leaks past the pi... | Class II |
| Apr 17, 2013 | CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CON... | During injection of cement, the water in the hydraulic pump leaks past the pi... | Class II |
| Apr 17, 2013 | CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFI... | During injection of cement, the water in the hydraulic pump leaks past the pi... | Class II |
| Jan 15, 2013 | DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. D... | Cement mixer used to prepare cement for surgery may not turn properly and may... | Class II |
| Jan 15, 2013 | DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. ... | Cement mixer used to prepare cement for surgery may not turn properly and may... | Class II |
| Jan 15, 2013 | DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Del... | Cement mixer used to prepare cement for surgery may not turn properly and may... | Class II |
| Jan 15, 2013 | DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000... | Cement mixer used to prepare cement for surgery may not turn properly and may... | Class II |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Iliu... | Class II |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Iliu... | Class II |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Iliu... | Class II |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Iliu... | Class II |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the iliu... | Class II |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Iliu... | Class II |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Iliu... | Class II |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Iliu... | Class II |
| Nov 7, 2012 | DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 ... | Polyaxial screws 8x 80 and larger may disassociate when inserting in the Iliu... | Class II |
| Jul 24, 2012 | DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The de... | A component within the handle of the Expedium Offset Torque Wrench is prematu... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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