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Oto Med Inc recalls Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be i
Recalled May 12, 2021 · FDA recall Z-1521-2021 · Oto Med
Hazard
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices. · FDA Class II
Units
415 devices
Sold at
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.
Description
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
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.
Manufacturer(s)
Oto Med Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →