Device product
MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
Z-1323-2016
Product summary
- Event
- Event 73259
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37
- Official record key
device-enforcement:Z-1323-2016
Official wording
Reason: Complaints that the cannula bent/broke during surgery.
Code information: 0913228216, 0414243005, 0215266350, 0415269875, and 0515271334.
Distribution pattern: Worldwide Distribution. US nationwide including Puerto Rico, Australia, Bangladesh, Czech Republic, India, Japan, Lebanon, New Zealand, Norway, Singapore, Switzerland, Taiwan, and Turkey.
Derived failure modes
-
Unknown
Complaints that the cannula bent/broke during surgery.