Recall Z-2733-2016 ยท HBG Drills, Burrs, Trephines & Accessories (Manual)
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
| Date | Sep 2, 2016 (initiated Aug 24, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging |
| Action | Consignees notified on August 12, 2016 via letter to identify and return product. |
| Quantity | 710 |
| Distribution | Nationwide and VA/govt/military. No foreign consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961113 | CNS INTERCHANGEABLE BIT CRANIAL DRILL Clinical Neuro Systems, LLC, Jun 5, 1996 |