Z-2348-2018Class II
microTargeting" Drive System, Product Number 66-ZD-MD-01
FHC, Inc. / initiated 2018-05-10 / Terminated / root cause: design
FHC, Inc. began a recall of microTargeting" Drive System, Product Number 66-ZD-MD-01 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2348-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- FHC, Inc.
- Product
- microTargeting" Drive System, Product Number 66-ZD-MD-01
- Product code
- HAW Neurological Stereotaxic Instrument
- 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.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Urgent Medical Device Recall notification letters were sent to customers on 5/10/18. The letters included the following instructions: FHC, Inc. Field Representatives will review your inventory and replace effected Depth Stop Adapters you have on hand with an improved design. In the interim, we advise that you do not over-tighten the Depth Stop Adapter screw. If low impedances or a short circuit is found, physicians should replace the lead prior to use and report the issue to FHC, Inc. or your local field rep.
- Quantity in commerce
- 2952 total
- 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 countries: Argentina, Australia, Canada, Columbia, Denmark, Ecuador, France, Germany, Great Britain, Italy, Japan, Norway, Romania, South Africa, Switzerland, Saudi Arabia, Taiwan.
- Product codes and lots
- UDI: 00873263003565
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2345-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2346-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2347-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2348-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2349-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2350-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2351-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2352-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2353-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2354-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2355-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2356-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2357-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2358-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2359-2018 | Class II | Terminated | Voluntary: Firm initiated |
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