Recall Z-1323-2016
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-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
Codes / lots: 0913228216, 0414243005, 0215266350, 0415269875, and 0515271334.
Reason for recall
Complaints that the cannula bent/broke during surgery.
FDA-determined cause: Component design/selection
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-1323-2016
- Initiated
- February 8, 2016
- Terminated
- August 12, 2016
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Quantity
- 37
- Distribution
- Worldwide Distribution. US nationwide including Puerto Rico, Australia, Bangladesh, Czech Republic, India, Japan, Lebanon, New Zealand, Norway, Singapore, Switzerland, Taiwan, and Turkey.
- Recalling firm
- MicroAire Surgical Instruments, LLC, Charlottesville, VA