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.
Reported: May 12, 2021 Initiated: December 7, 2020 #Z-1520-2021
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.
Details
- Recalling Firm
- Oto Med Inc
- Units Affected
- 5,092 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.
- Location
- Lake Havasu City, AZ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Oto Med Inc. Units affected: 5,092 devices.
Why was this product recalled? ▼
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 12, 2021. Severity: Moderate. Recall number: Z-1520-2021.
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