FHC, Inc. Recall: microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
FHC, Inc. Recall: microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: FHC, Inc.; Product: microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA; Reason for recall: The FHC Depth Stop Adapter may cause damag
| Recalling firm | FHC, Inc. |
|---|---|
| Product | microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA |
| Reason for recall | 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | 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 c |
| Recall initiated | 20180510 |
| Recall number | Z-2351-2018 |
| Category | device |
| State | ME |
| Country | United States |
$29/mo
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