Home / Recalls / Oto Med Inc / Z-1520-2021

Z-1520-2021 Class II Ongoing

Recalled by Oto Med Inc — Lake Havasu City, AZ

Recall Details

Product Type: Devices
Report Date: May 12, 2021
Initiation Date: December 7, 2020
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5,092 devices

Product Description

Grace Medical REF S-3500 *** COX 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.

Distribution Pattern

Worldwide distribution - U.S. Nationwide distribution including in the states of MN, IL, PA, WI, GA, SD, FL, AR, MA, AZ, TX, MO, NC, CA, UT, DE, OR, IN, CO, AL, OH, NY, WA, DC, TN, NH, VT, VA, SC, MI, WI, MS, IA, NJ, MD, KS, CT, LA, ME, KY, HI, TN, RI, NV, ID and the countries of Argentina, Brazil, Colombia, Chile, Hong Kong, South Africa, United Arab Emirates, Taiwan, Canada, India.

Code Information

UDI Code: 008500001260060 Lot Numbers: 019120G(2) 029119G(2) 039118G(2) 049119G(2) 0712119G(2) 0812118G(2) 0912118G(2) 1012119G(2) 1212118G(2) 200602