Integra Limited

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1338-2019Class IIIntegra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix iMarch 31, 2019
Z-1089-2019Class IIIntegra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product Usage: The bioMarch 1, 2019
Z-1090-2019Class IIIntegra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The biMarch 1, 2019
Z-1091-2019Class IIIntegra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product Usage: The biMarch 1, 2019
Z-0117-2014Class IIBrand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / CatSeptember 10, 2013
Z-2056-2013Class IIIntegra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla RetJuly 17, 2013
Z-2458-2012Class IIThe MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿July 27, 2012
Z-2457-2012Class IIThe MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿July 27, 2012
Z-2028-2012Class IIIntegra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart EndoscopiMay 23, 2012