Z-1328-2016 Class II Terminated
FDA device recall Z-1328-2016 was initiated by MicroAire Surgical Instruments, LLC on February 8, 2016 and is designated Class II. Reason for recall: MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery. Accordingly, … The recall status is terminated (terminated February 14, 2017). Affected quantity: 145 manufactured and distributed.
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2016
- Initiation Date
- February 8, 2016
- Termination Date
- February 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 145 manufactured and distributed
Product Description
MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device
Reason for Recall
MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery. Accordingly, the PAL-R4011XL has also been put on production hold until further notice.
Distribution Pattern
Worldwide Distribution - US Nationwide
Code Information
Include lot numbers/serial numbers 0913228216, 0414243005, 0215266350, 0415269875, 0515271334