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Zimmer Biomet, Inc. recalls SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indi
Recalled November 7, 2018 · FDA recall Z-0287-2019 · 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
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →