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.
Check against the official notice below — it lists the full affected range.
Oto Med Inc is recalling 415 Grace Medical REF S-4500 spineX Bone Dust Collector devices with stainless steel filters, which are intended for insertion into suction tubes during early stages of ear surgery. The recall was initiated after internal age testing discovered holes in the sterile Tyvek pouches that package these devices. The affected devices were distributed worldwide, including throughout the United States and in Argentina, Brazil, Colombia, Chile, Hong Kong, South Africa, United Arab Emirates, Taiwan, Canada, and India, with lot numbers 019120 G(2), 0712119 G(2), 0912118 G(2), and 1012119 G(2).
The source document does not specify a remedy or recommended action for consumers who may have received these devices.
Written by software from the official notice below. Not reviewed by a lawyer.
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Reason for recall: During internal Age Testing, holes were found in the sterile Tyvek pouches of the 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. Quantity: 415 devices Lot/code info: UDI Code: 00850000126077 Lot Numbers: 019120 G(2) 0712119 G(2) 0912118 G(2) 1012119 G(2)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.