Cns Interchangeable Bit Cranial Drill

• • Ongoing Z-1873-2024 FDA Class II ·initiated 17 Apr 2024

  Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.

• 11 recalls, same reason

  • Ongoing Z-1198-2024 FDA Class II ·initiated 19 Jan 2024
  • Ongoing Z-1203-2024 FDA Class II ·initiated 19 Jan 2024
  • Ongoing Z-1201-2024 FDA Class II ·initiated 19 Jan 2024
  • Ongoing Z-1193-2024 FDA Class II ·initiated 19 Jan 2024
  • Ongoing Z-1200-2024 FDA Class II ·initiated 19 Jan 2024
  • Ongoing Z-1195-2024 FDA Class II ·initiated 19 Jan 2024
  • Ongoing Z-1199-2024 FDA Class II ·initiated 19 Jan 2024
  • Ongoing Z-1202-2024 FDA Class II ·initiated 19 Jan 2024
  • Ongoing Z-1196-2024 FDA Class II ·initiated 19 Jan 2024
  • Ongoing Z-1197-2024 FDA Class II ·initiated 19 Jan 2024
  • Ongoing Z-1194-2024 FDA Class II ·initiated 19 Jan 2024

  A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.

• 2 recalls, same reason

  • Ongoing Z-0491-2024 FDA Class II ·initiated 19 Oct 2023
  • Ongoing Z-0492-2024 FDA Class II ·initiated 19 Oct 2023

  Defect in the outer packaging of the Cranial Access Kits can cause the packaging to split without any additional forces outside compromising the sterility of the device

• 7 recalls, same reason

  • Ongoing Z-0497-2024 FDA Class II ·initiated 19 Oct 2023
  • Ongoing Z-0496-2024 FDA Class II ·initiated 19 Oct 2023
  • Ongoing Z-0499-2024 FDA Class II ·initiated 19 Oct 2023
  • Ongoing Z-0498-2024 FDA Class II ·initiated 19 Oct 2023
  • Ongoing Z-0495-2024 FDA Class II ·initiated 19 Oct 2023
  • Ongoing Z-0494-2024 FDA Class II ·initiated 19 Oct 2023
  • Ongoing Z-0493-2024 FDA Class II ·initiated 19 Oct 2023

  Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device

• • Terminated Z-2733-2016 FDA Class II ·initiated 24 Aug 2016

  Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon" Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found that product seals may become open during extreme distribution conditions and render the device unsterile.

• • Terminated Z-2260-2013 FDA Class II ·initiated 4 Sep 2013 ·on shared 510(k) K961113

  Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.

• 12 recalls, same reason

  • Terminated Z-0751-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0750-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0748-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0759-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0755-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0752-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0756-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0757-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0753-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0758-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0754-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011
  • Terminated Z-0749-2012 FDA Unclassified (pre-2012) ·initiated 21 Dec 2011

  Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.

• • Terminated Z-2194-2011 FDA Unclassified (pre-2012) ·initiated 22 Feb 2011

  Outer packaging of Combo Kit was mislabeled with an incorrect lot number.

• • Terminated Z-2171-2011 FDA Unclassified (pre-2012) ·initiated 22 Feb 2011

  Outer box of Monitoring Kit was mislabeled with the incorrect part number.

• • Terminated Z-2084-2009 FDA Unclassified (pre-2012) ·initiated 13 Jul 2009

  Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.

• • Terminated Z-1097-04 FDA Unclassified (pre-2012) ·initiated 19 Mar 2003 ·on shared 510(k) K961113

  The outer labeling of the convenience kit indicates that an additional bottle of Sodium Chloride (saline) solution is included in the Custom Kit 31176; however, an additional bottle of 1% Xylocaine was included in the Custom Kit.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K961113 ↗

FDA Product Code

HBG

Device Class

Class II

Regulation

21 CFR Part 882.4300

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Clinical Neuro Systems Monitorr Icp Lumbar Cathete

  Class II

  FDA 510(k) K922936 Active Cleared 26 Aug 1992

• Clinical Neuro Systems Cranial Drill

  Class II

  FDA 510(k) K930229 Active Cleared 16 Mar 1993

• Clinical Neuro Systems Monitorr Icp Ventricular Ca

  Class II

  FDA 510(k) K922941 Active Cleared 26 Aug 1992

• Clinical Neuro Syst Monitorr Ext Csf Drain/Moni Sy

  Class II

  FDA 510(k) K920156 Active Cleared 16 Mar 1992