Recall Z-2359-2018 ยท HAW Neurological Stereotaxic Instrument
FHC, Inc.
microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
| Date | May 10, 2018 |
| Status | Terminated |
| Reason | 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 | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011992 | FHC MICROTARGETING DRIVE SYSTEM FHC, Inc., Aug 14, 2001 |