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Recall Observatory FDA recall evidence

Device product

MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device

Z-1328-2016

February 08, 2016

Class II

Product summary

Firm
MicroAire Surgical Instruments, LLC
Event
Event 73373
Status
Terminated
Classification
Class II
Quantity
145 manufactured and distributed
Official record key
device-enforcement:Z-1328-2016

Official wording

Reason: 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.

Code information: Include lot numbers/serial numbers 0913228216, 0414243005, 0215266350, 0415269875, 0515271334

Distribution pattern: Worldwide Distribution - US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.