Z-1521-2021 Class II Ongoing
FDA device recall Z-1521-2021 was initiated by Oto Med Inc on December 7, 2020 and is designated Class II. Reason for recall: During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices. The recall status is ongoing. Affected quantity: 415 devices.
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
- 415 devices
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.
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: 00850000126077 Lot Numbers: 019120 G(2) 0712119 G(2) 0912118 G(2) 1012119 G(2)