Recall Z-1323-2016— MicroAire Surgical Instruments, LLC

Name: FDA recall Z-1323-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-08

Class II · Terminated

Class II FDA medical device recall by MicroAire Surgical Instruments, LLC, initiated 2016-02-08, terminated 2016-08-12. It names one FDA 510(k) clearance: K973268. Product: MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula. Reason: Complaints that the cannula bent/broke during surgery..

Recalling firm: MicroAire Surgical Instruments, LLC
Classification: Class II
Status: Terminated
Initiated: 2016-02-08
Terminated: 2016-08-12
Firm location: Charlottesville, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K973268 — MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEMMicroaire Surgical Instruments, Inc.·cleared 1997-11-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula

Reason for recall

Complaints that the cannula bent/broke during surgery.

Data sourced from openFDA. This site is unofficial and independent of the FDA.