FDA-Device2018-11-07Class I
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
Zimmer Biomet, Inc.
Hazard
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
Sold states
US Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV ; and country of: Australia.
Affected count
4,879 units (2,982 units have been implanted and 537 have been scrapped)
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0286-2019Don't want to check this manually?
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