Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product U...
FDA Recall #Z-1521-2021 — Class II — December 7, 2020
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.
Recalling Firm
Oto Med Inc — Lake Havasu City, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
415 devices
Distribution
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: 00850000126077 Lot Numbers: 019120 G(2) 0712119 G(2) 0912118 G(2) 1012119 G(2)
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated