Device product
Surgical punch; sealed pouches packed in punch shelf box Intended for use by trained surgeons to create circular cuts in soft tissue or openings in soft vessel walls during surgical procedures.
Z-0813-2018
Product summary
- Event
- Event 79274
- Status
- Terminated
- Classification
- Class II
- Quantity
- 411,486 units
- Official record key
device-enforcement:Z-0813-2018
Official wording
Reason: Surgical punches are being recalled due to potential packaging damage which may have occurred during transportation resulting in loss of sterility.
Code information: 080-271 (9108 units); 080-351 (41712 units); 080-401(219954 units); 080-403 (1368 units); 080-451 (83190 units); 080-481 (32556 units); 080-501 (23598 units)
Distribution pattern: Worldwide Distribution - USA Distribution
Derived failure modes
-
Sterility assurance
loss of sterility