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Zimmer Biomet, Inc. recalls EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the
Recalled November 7, 2018 · FDA recall Z-0286-2019 · Zimmer Biomet
Hazard
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met. · FDA Class I
Units
4,879 units (2,982 units have been implanted and 537 have been scrapped)
Sold at
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.
Description
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
Product
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →