Recall Z-1328-2016
MicroAire Surgical Instruments, LLC · initiated February 8, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MicroAire PAL Cannula Product Usage - Power Aspiration Device
Codes / lots: Include lot numbers/serial numbers 0913228216, 0414243005, 0215266350, 0415269875, 0515271334
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
The firm is sending letters to all customers who have received PAL-R4011XL from August 2013- October 2015. The firm sent these letters by UPS to expedite the delivery and for traceability.
Details
- Recall number
- Z-1328-2016
- Initiated
- February 8, 2016
- Terminated
- February 14, 2017
- Product code
- GEA – Cannula, Surgical, General & Plastic Surgery
- Quantity
- 145 manufactured and distributed
- Distribution
- Worldwide Distribution - US Nationwide
- Recalling firm
- MicroAire Surgical Instruments, LLC, Charlottesville, VA