Z-1323-2016 Class II Terminated
FDA device recall Z-1323-2016 was initiated by MicroAire Surgical Instruments, LLC on Feb 8, 2016 and is designated Class II. Reason for recall: Complaints that the cannula bent/broke during surgery. The recall status is terminated (terminated Aug 12, 2016). Affected quantity: 37.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 13, 2016
- Initiation Date
- Feb 8, 2016
- Termination Date
- Aug 12, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37
Product Description
MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
Reason for Recall
Complaints that the cannula bent/broke during surgery.
Distribution Pattern
Worldwide Distribution. US nationwide including Puerto Rico, Australia, Bangladesh, Czech Republic, India, Japan, Lebanon, New Zealand, Norway, Singapore, Switzerland, Taiwan, and Turkey.
Code Information
0913228216, 0414243005, 0215266350, 0415269875, and 0515271334.