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Sign in to claim this brandDepuy Spine, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 325 Paramount Drive, RAYNHAM, MA, 02767
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1526439
- DUNS Number
- —
Catalogue (4164)
Page 2 of 84| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Expedium | 279782210 | FDA UDI | Class I | Active |
| Vsp | 30263230H | FDA UDI | Class II | Unknown |
| Keystone | 282112112 | FDA UDI | Class I | Unknown |
| Expedium | 186132560 | FDA UDI | Class II | Active |
| Vsp | 61005555 | FDA UDI | Class II | Unknown |
| Monarch | 277050700 | FDA UDI | Class I | Unknown |
| Isola | 205046 | FDA UDI | Class I | Active |
| Vsp | 202572 | FDA UDI | Class I | Unknown |
| Summit | 274650103 | FDA UDI | Class I | Unknown |
| Uniplate | 189706014 | FDA UDI | Class II | Active |
| Monarch | 177067785 | FDA UDI | Class II | Unknown |
| Vsp | 30267330 | FDA UDI | Class II | Unknown |
| Spotlight | 282912550 | FDA UDI | Class II | Active |
| Monarch | 177067780 | FDA UDI | Class II | Unknown |
| Expedium | 186212555 | FDA UDI | Class II | Unknown |
| Isola | 203003 | FDA UDI | Class II | Active |
| Moss | 175580025 | FDA UDI | Class II | Active |
| Isola | 5000207 | FDA UDI | Class II | Unknown |
| Keystone | 282101211 | FDA UDI | Class I | Active |
| Expedium | 286280800 | FDA UDI | Class I | Active |
| Isola | 2030540 | FDA UDI | Class II | Unknown |
| Expedium | 186200004 | FDA UDI | Class II | Unknown |
| Spotlight | 282921611 | FDA UDI | Class II | Active |
| Expedium | 186212635 | FDA UDI | Class II | Unknown |
| Isola | 50009935 | FDA UDI | Class II | Unknown |
| Summit | 174618728 | FDA UDI | Class II | Unknown |
| Summit | 274668037 | FDA UDI | Class I | Unknown |
| Monarch | 177067645 | FDA UDI | Class II | Unknown |
| Alif Vertigraft | 273516116 | FDA UDI | Class I | Active |
| Expedium | 188112035 | FDA UDI | Class II | Unknown |
| Cougar | 187115212 | FDA UDI | Class II | Active |
| Moss | 275015760 | FDA UDI | Class I | Unknown |
| Plif | 273121001 | FDA UDI | Class I | Unknown |
| Saber Lumbar I/F Cage | 287013015 | FDA UDI | Class I | Unknown |
| Vsp | 22251A | FDA UDI | Class II | Unknown |
| Cougar | 187110212 | FDA UDI | Class II | Active |
| Mountaineer | 288320406 | FDA UDI | Class I | Active |
| Bengal | 177300330 | FDA UDI | Class II | Active |
| Moss | 275010350 | FDA UDI | Class I | Unknown |
| Uniplate | 289705012 | FDA UDI | Class I | Active |
| Expedium | 188102835 | FDA UDI | Class II | Unknown |
| Monarch | 177046250 | FDA UDI | Class II | Unknown |
| Monarch | 177016250 | FDA UDI | Class II | Unknown |
| Monarch | 277491200 | FDA UDI | Class I | Unknown |
| Moss | 279772701 | FDA UDI | Class I | Unknown |
| Vsp | 60008545 | FDA UDI | Class II | Unknown |
| Isola | 5003126 | FDA UDI | Class II | Unknown |
| Isola | 50103260 | FDA UDI | Class II | Unknown |
| Viper | 186788200 | FDA UDI | Class II | Active |
| Expedium | 286280000 | FDA UDI | Class I | Active |
Related Companies
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Importers
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Notified Bodies
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Authorities
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FDA Recalls (57)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 20, 2022 | Z-1324-2022 | — | open, classified | 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 20, 2022 | Z-1323-2022 | — | open, classified | 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 |
| Apr 8, 2019 | Z-1225-2019 | — | terminated | A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants. |
| Apr 8, 2019 | Z-1226-2019 | — | terminated | A complaint trend was observed for post-operative loss of height and migration for Concorde Lift G3+ implants. |
| Dec 15, 2017 | Z-1300-2018 | — | terminated | 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. |
| Oct 12, 2016 | Z-0627-2017 | — | terminated | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. |
| Oct 12, 2016 | Z-0628-2017 | — | terminated | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. |
| Oct 12, 2016 | Z-0629-2017 | — | terminated | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. |
| Oct 12, 2016 | Z-0624-2017 | — | terminated | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. |
| Oct 12, 2016 | Z-0626-2017 | — | terminated | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. |
| Oct 12, 2016 | Z-0625-2017 | — | terminated | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. |
| Oct 12, 2016 | Z-0630-2017 | — | terminated | SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging. |
| Nov 20, 2015 | Z-0454-2016 | — | terminated | 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 |
| Apr 21, 2015 | Z-1674-2015 | — | terminated | Device does not mate as intended. |
| Jul 31, 2013 | Z-0096-2014 | — | terminated | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. |
| Jul 31, 2013 | Z-0095-2014 | — | terminated | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. |
| Jul 31, 2013 | Z-0093-2014 | — | terminated | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. |
| Jul 31, 2013 | Z-0097-2014 | — | terminated | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. |
| Jul 31, 2013 | Z-0094-2014 | — | terminated | Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. |
| Apr 17, 2013 | Z-2132-2013 | — | terminated | 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. |
| Apr 17, 2013 | Z-2134-2013 | — | terminated | 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. |
| Apr 17, 2013 | Z-2133-2013 | — | terminated | 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. |
| Jan 15, 2013 | Z-0963-2013 | — | terminated | Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck |
| Jan 15, 2013 | Z-0961-2013 | — | terminated | Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck |
| Jan 15, 2013 | Z-0960-2013 | — | terminated | Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck |
| Jan 15, 2013 | Z-0962-2013 | — | terminated | Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck |
| Nov 7, 2012 | Z-0708-2013 | — | terminated | 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 |
| Nov 7, 2012 | Z-0707-2013 | — | terminated | 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 |
| Nov 7, 2012 | Z-0706-2013 | — | terminated | 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 |
| Nov 7, 2012 | Z-0705-2013 | — | terminated | 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 |
| Nov 7, 2012 | Z-0710-2013 | — | terminated | 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 |
| Nov 7, 2012 | Z-0713-2013 | — | terminated | 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. |
| Nov 7, 2012 | Z-0709-2013 | — | terminated | 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 |
| Nov 7, 2012 | Z-0711-2013 | — | terminated | 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 |
| Nov 7, 2012 | Z-0712-2013 | — | terminated | 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 |
| Jul 24, 2012 | Z-0685-2013 | — | terminated | 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. |
| Mar 22, 2011 | Z-2102-2011 | — | terminated | Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle |
| Mar 22, 2011 | Z-2103-2011 | — | terminated | Mislabeled: Package labeled (11g x 6 inch) contains a 13g x 4-inch side hole needle |
| Oct 2, 2010 | Z-0818-2011 | — | terminated | The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy |
| Oct 2, 2010 | Z-0819-2011 | — | terminated | The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy |
| Oct 2, 2010 | Z-0817-2011 | — | terminated | The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy |
| Feb 11, 2009 | Z-1670-2009 | — | terminated | Tip of Driver may break during use |
| Oct 10, 2006 | Z-0134-2007 | — | terminated | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Z-0136-2007 | — | terminated | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Z-0143-2007 | — | terminated | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Z-0130-2007 | — | terminated | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Z-0138-2007 | — | terminated | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Z-0140-2007 | — | terminated | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Z-0135-2007 | — | terminated | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Z-0133-2007 | — | terminated | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Z-0131-2007 | — | terminated | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Z-0132-2007 | — | terminated | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Z-0141-2007 | — | terminated | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Z-0142-2007 | — | terminated | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Z-0144-2007 | — | terminated | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Z-0139-2007 | — | terminated | Sterility of device is compromised due to loss of package integrity |
| Oct 10, 2006 | Z-0137-2007 | — | terminated | Sterility of device is compromised due to loss of package integrity |