Z-2733-2016 Class II Terminated
FDA device recall Z-2733-2016 was initiated by Integra LifeSciences Corp. d.b.a. Integra Pain Management on August 24, 2016 and is designated Class II. 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… The recall status is terminated (terminated March 30, 2017). Affected quantity: 710.
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