FDA-Device2018-07-11Class II
microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
FHC, Inc.
Hazard
The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short circuit between one or multiple electrode pairs in the lead, and has resulted in the need to remove and replace the implanted lead intraoperative or in a follow-up procedure.
Sold states
The devices were distributed to the following US states: AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The devices were distributed to the following foreign countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
Affected count
2952 total
Manufactured in
1201 Main St, Bowdoin, ME, United States
Products
microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2351-2018Don't want to check this manually?
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