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Terminated

MicroAire PAL Cannula Product Usage - Power Aspiration Device

FDA Recall Z-1328-2016 · Posted None

Recalling FirmMicroAire Surgical Instruments, LLC
Recall StatusTerminated
Product CodeGEA
Date Initiated2016-02-08
Date Terminated2017-02-14
Product Quantity145 manufactured and distributed

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.

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

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - US Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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