MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
FDA Recall Z-1323-2016 · Posted None
Recalling FirmMicroAire Surgical Instruments, LLC
Recall StatusTerminated
Product CodeBTA
Date Initiated2016-02-08
Date Terminated2016-08-12
Product Quantity37
Reason for Recall
Complaints that the cannula bent/broke during surgery.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution. US nationwide including Puerto Rico, Australia, Bangladesh, Czech Republic, India, Japan, Lebanon, New Zealand, Norway, Singapore, Switzerland, Taiwan, and Turkey.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.