Reported Jul 11, 2018 · Terminated
microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
FHC, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: FHC, Inc. · 1201 Main St · Bowdoin, ME · 04287-7302
Is this the product you have?
- microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
- Lot codes and dates
- UDI00873263002162
- Amount recalled
- 2952 total
This recall covers 15 products
The agency filed one notice per product. You are reading one of them; the other 14 are below.
2 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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