Recall Z-1521-2021— Oto Med Inc

Name: FDA recall Z-1521-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-07

Class II · Ongoing

Class II FDA medical device recall by Oto Med Inc, initiated 2020-12-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.. Reason: During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices..

Recalling firm: Oto Med Inc
Classification: Class II
Status: Ongoing
Initiated: 2020-12-07
Firm location: Lake Havasu City, AZ, United States

Product description

Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

Reason for recall

During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.

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