Integra LifeSciences Corporation

FDA Regulatory Profile

Summary

Total Recalls
29
510(k) Clearances
65
Inspections
17
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-2777-2016Class IIIntegra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra¿ DermalMarch 11, 2016
Z-1084-2015Class IIThe MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: December 19, 2014
Z-1697-2014Class IIIntegra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 3March 28, 2014
Z-1736-2013Class IIIntegra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treMay 9, 2013
Z-1288-2013Class IIINSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgicMarch 28, 2013
Z-1283-2013Class IISuturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absMarch 28, 2013
Z-1284-2013Class IIDuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implMarch 28, 2013
Z-1282-2013Class IIDural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable implant for repair of dural defeMarch 28, 2013
Z-1286-2013Class IINeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheralMarch 28, 2013
Z-1291-2013Class IIColla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound DrMarch 28, 2013
Z-1292-2013Class IICollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound DreMarch 28, 2013
Z-1301-2013Class IIBioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implMarch 28, 2013
Z-1294-2013Class IIHeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound DresMarch 28, 2013
Z-1290-2013Class IIHelitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (otheMarch 28, 2013
Z-1298-2013Class IIOraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implanMarch 28, 2013
Z-1299-2013Class IIBioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable Collagen Membrane is anMarch 28, 2013
Z-1285-2013Class IIDuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implanMarch 28, 2013
Z-1300-2013Class IILayershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant March 28, 2013
Z-1293-2013Class IICollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound DreMarch 28, 2013
Z-1289-2013Class IIHelistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (otherMarch 28, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemOctober 8, 2025
K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)April 9, 2025
K240493CUSA® Clarity Ultrasonic Surgical Aspirator SystemJuly 11, 2024
K230427CUSA Clarity Ultrasonic Surgical Aspirator SystemJuly 11, 2023
K221835CUSA Clarity Ultrasonic Surgical Aspirator SystemAugust 22, 2022
K221763CUSA Clarity Ultrasonic Surgical Aspirator SystemJuly 15, 2022
K210128INTEGRA Wound Matrix (Macro-Channels)October 8, 2021
K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE SJuly 27, 2021
K193346Codman Surgical Patties & StripsNovember 20, 2020
K201507Cadence Total Ankle SystemJune 29, 2020
K200774CUSA Clarity Ultrasonic Surgical Aspirator SystemJune 23, 2020
K190588Integra TITAN Reverse Shoulder SystemDecember 2, 2019
K191684MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF DrainageOctober 11, 2019
K190180CUSA Clarity Ultrasonic Surgical Aspirator SystemApril 1, 2019
K182809CUSA Clarity Ultrasonic Surgical Aspirator SystemDecember 7, 2018
K182801Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting CableNovember 27, 2018
K181639Panta 2 Arthrodesis Nail SystemNovember 2, 2018
K181999Integra TITAN Reverse Shoulder SystemOctober 12, 2018
K173717Integra TITAN Reverse Shoulder SystemJune 21, 2018
K172595CUSA Excel+ Ultrasonic Surgical Aspirator SystemSeptember 28, 2017