MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
This recall has been terminated (originally issued February 8, 2016).
- Recall Initiated
- February 8, 2016
- Terminated
- August 12, 2016
- Recall Number
- Z-1323-2016
- Quantity
- 37
- Firm Location
- Charlottesville, VA
- Official Source
- View on FDA website ↗
Reason for Recall
Complaints that the cannula bent/broke during surgery.
Distribution
Worldwide Distribution. US nationwide including Puerto Rico, Australia, Bangladesh, Czech Republic, India, Japan, Lebanon, New Zealand, Norway, Singapore, Switzerland, Taiwan, and Turkey.
Lot / Code Info
0913228216, 0414243005, 0215266350, 0415269875, and 0515271334.
Root 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.
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