EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
Reported: November 7, 2018 Initiated: February 19, 2018 #Z-0286-2019
Product Description
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
Reason for Recall
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 4,879 units (2,982 units have been implanted and 537 have been scrapped)
- Distribution
- 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.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.. Recalled by Zimmer Biomet, Inc.. Units affected: 4,879 units (2,982 units have been implanted and 537 have been scrapped).
Why was this product recalled? ▼
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 7, 2018. Severity: Critical. Recall number: Z-0286-2019.
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