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
Reported: November 7, 2018 Initiated: February 19, 2018 #Z-0287-2019
Product Description
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
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? ▼
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. 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-0287-2019.
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