Home / Recalls / Integra LifeSciences Corp. d.b.a. Integra Pain Management / Z-2733-2016

Z-2733-2016 Class II Terminated

Recalled by Integra LifeSciences Corp. d.b.a. Integra Pain Management — Salt Lake City, UT

Recall Details

Product Type
Devices
Report Date
September 14, 2016
Initiation Date
August 24, 2016
Termination Date
March 30, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
710

Product Description

Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND

Reason for Recall

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.

Distribution Pattern

Nationwide and VA/govt/military. No foreign consignees.

Code Information

Lot W1605101: Exp 2016-12 Lot W1605103: Exp 2016-11 Lot W1605106: Exp 2016-11 Lot W1606063: Exp 2016-12 Lot W1605101: Exp 2016-12 W1605103: 2016-11 W1605106: 2016-11 W1606063: 2016-12

Other recalls by Integra LifeSciences Corp. d.b.a. Integra Pain Management

  • Z-2868-2016 Class II — PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide li (August 24, 2016)
  • Z-2684-2016 Class II — INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile. (August 4, 2016)
  • Z-0193-2016 Class II — Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices (September 22, 2015)
  • Z-2056-2015 Class II — Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inc (May 1, 2015)
  • Z-1544-2015 Class II — Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch (March 30, 2015)
  • Z-0551-2014 Class II — Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Ac (November 26, 2013)
  • Z-0533-2014 Class II — Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 3 (October 28, 2013)
  • Z-2260-2013 Class II — Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHIT (September 4, 2013)
  • Z-1943-2012 Class III — Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, (June 7, 2012)