Recall Z-1328-2016 ยท GEA Cannula, Surgical, General & Plastic Surgery
MicroAire Surgical Instruments, LLC
MicroAire PAL Cannula Product Usage - Power Aspiration Device
| Date | Feb 8, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 145 manufactured and distributed |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.