Recall Z-1328-2016— MicroAire Surgical Instruments, LLC
Class II · Terminated
Class II FDA medical device recall by MicroAire Surgical Instruments, LLC, initiated 2016-02-08, terminated 2017-02-14. FDA's recall record names no specific 510(k) clearance for this event. Product: MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device. 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..
- Recalling firm
- MicroAire Surgical Instruments, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-08
- Terminated
- 2017-02-14
- Firm location
- Charlottesville, VA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.