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DePuy Spine, Inc.

47 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C) recall (Z-1225-2019)DePuy Spine, Inc.2019-04-27
Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023 recall (Z-1226-2019)DePuy Spine, Inc.2019-04-27
Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AE recall (Z-0454-2016)DePuy Spine, Inc.2015-12-21
EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG recall (Z-1674-2015)DePuy Spine, Inc.2015-05-26
PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding recall (Z-0093-2014)DePuy Spine, Inc.2013-10-23
PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Hold recall (Z-0094-2014)DePuy Spine, Inc.2013-10-23
PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holdi recall (Z-0095-2014)DePuy Spine, Inc.2013-10-23
PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Hold recall (Z-0096-2014)DePuy Spine, Inc.2013-10-23
PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are inte recall (Z-0097-2014)DePuy Spine, Inc.2013-10-23
CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal C recall (Z-2132-2013)DePuy Spine, Inc.2013-09-03
CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 The CONFIDENCE Sp recall (Z-2133-2013)DePuy Spine, Inc.2013-09-03
CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFIDENCE Spinal Cemen recall (Z-2134-2013)DePuy Spine, Inc.2013-09-03
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFID recall (Z-0960-2013)DePuy Spine, Inc.2013-03-18
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFI recall (Z-0961-2013)DePuy Spine, Inc.2013-03-18
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of recall (Z-0962-2013)DePuy Spine, Inc.2013-03-18
DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENC recall (Z-0963-2013)DePuy Spine, Inc.2013-03-18
DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Compo recall (Z-0705-2013)DePuy Spine, Inc.2013-01-24
DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Compo recall (Z-0706-2013)DePuy Spine, Inc.2013-01-24
DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Comp recall (Z-0707-2013)DePuy Spine, Inc.2013-01-24
DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Compo recall (Z-0708-2013)DePuy Spine, Inc.2013-01-24
DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Comp recall (Z-0709-2013)DePuy Spine, Inc.2013-01-24
DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Comp recall (Z-0710-2013)DePuy Spine, Inc.2013-01-24
DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant Com recall (Z-0711-2013)DePuy Spine, Inc.2013-01-24
DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Com recall (Z-0712-2013)DePuy Spine, Inc.2013-01-24
DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Comp recall (Z-0713-2013)DePuy Spine, Inc.2013-01-24
DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended recall (Z-0685-2013)DePuy Spine, Inc.2013-01-16
Confidence Diamond Tip Introducer Needle 11G x 6-Inch Product Code: 2839-03-611 The Confid recall (Z-2102-2011)DePuy Spine, Inc.2011-04-27
Confidence Introducer Needle Side Hole 13G x 4-Inch Product Code: 2839-04-413 The Confiden recall (Z-2103-2011)DePuy Spine, Inc.2011-04-27
Depuy Spine Mountaineer OCT Caddy Set, Non-Sterile Product Code: 2883-90-000 The MOUNTAINE recall (Z-0817-2011)DePuy Spine, Inc.2010-12-27
Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set, , Non Sterile Product Code: 288 recall (Z-0818-2011)DePuy Spine, Inc.2010-12-27
Depuy Spine Mountaineer OCT Spinal System Screw Caddy, Non Sterile Product Code: 2883-90-4 recall (Z-0819-2011)DePuy Spine, Inc.2010-12-27
DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 289 recall (Z-1670-2009)DePuy Spine, Inc.2009-08-14
DePuy Spine Bremer 3-D Halo Crown System Product Code: 2923-01-100 recall (Z-0130-2007)DePuy Spine, Inc.2006-11-02
0 Degree Slider Set, DePuy Spine Bremer Halo System Product Code: 2923-01-010 recall (Z-0131-2007)DePuy Spine, Inc.2006-11-02
12 Degree Slider Set, DePuy Spine Bremer Halo System Product Code: 2923-01-020 recall (Z-0132-2007)DePuy Spine, Inc.2006-11-02
Small Halo Crown, DePuy Spine Bremer Halo System Product Number: HT025 recall (Z-0133-2007)DePuy Spine, Inc.2006-11-02
Large Halo Crown, DePuy Spine Bremer Halo System Product Number: HT026 recall (Z-0134-2007)DePuy Spine, Inc.2006-11-02
Small Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Code: HT025HI recall (Z-0135-2007)DePuy Spine, Inc.2006-11-02
Large Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Number: HT026HI recall (Z-0136-2007)DePuy Spine, Inc.2006-11-02
Adjustable Ring Traction Set, Size B, DePuy Spine Bremer Halo System Product Code: HT001 recall (Z-0137-2007)DePuy Spine, Inc.2006-11-02
Adjustable Ring Traction Set, Size C, DePuy Spine Bremer Halo System Product Code: HT002 recall (Z-0138-2007)DePuy Spine, Inc.2006-11-02
Small Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT001 recall (Z-0139-2007)DePuy Spine, Inc.2006-11-02
Large Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT002 recall (Z-0140-2007)DePuy Spine, Inc.2006-11-02
Standard Skull Rings, DePuy Spine Bremer Halo System Product Code: AC007 recall (Z-0141-2007)DePuy Spine, Inc.2006-11-02
Skull pins w/Torque, DePuy Spine Bremer Halo System Product Code: AC014 recall (Z-0142-2007)DePuy Spine, Inc.2006-11-02
Extra Long Skull Pins, DePuy Spine Bremer Halo System Product Number: AC018 recall (Z-0143-2007)DePuy Spine, Inc.2006-11-02
HI Fix Skull Pins, DePuy Spine Bremer Halo System Product Code: AC020 recall (Z-0144-2007)DePuy Spine, Inc.2006-11-02

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Every clearance here is in the API, with alerts when new ones post.