Z-0752-2017 Class II Terminated
FDA device recall Z-0752-2017 was initiated by Integra York PA, Inc on October 28, 2016 and is designated Class II. Reason for recall: The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument. The recall status is terminated (terminated April 17, 2017). Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 21, 2016
- Initiation Date
- October 28, 2016
- Termination Date
- April 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
Metzenbaum Scissors 7 , Curved, Sterile The Metzenbaum Scissors 7 , Curved Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures.
Reason for Recall
The Chevron seals of 6x10 Tyvek peel pouch used to package the sterile instruments may separate causing the packages to open and compromise sterility of the instrument.
Distribution Pattern
US Distribution in NC and TX.
Code Information
Catalog # ST5-182; lot# 355