Device product
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.
Z-0752-2017
Product summary
- Event
- Event 75710
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 units
- Official record key
device-enforcement:Z-0752-2017
Official wording
Reason: 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.
Code information: Catalog # ST5-182; lot# 355
Distribution pattern: US Distribution in NC and TX.
Derived failure modes
-
Sterility assurance
package the sterile instruments may separate causing the packages to open and compromise sterility