Augmentation devices failed bacterial endotoxin testing.
Reason for recall: Augmentation devices failed bacterial endotoxin testing. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, France, Germany, Italy, Japan, Korea, Spain, Switzerland, United Kingdom, United Arab Emirates, Slovenia. Quantity: N/A Lot/code info: A10011001/GTIN: 00850003396019
00850003396019
Official record: FDA (Device enforcement) ↗
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