| Class 2 Device Recall microTargeting" Drive System, Product Number MTDS01 | |
Date Initiated by Firm | May 10, 2018 |
Create Date | July 05, 2018 |
Recall Status1 |
Terminated 3 on April 30, 2019 |
Recall Number | Z-2346-2018 |
Recall Event ID |
80148 |
510(K)Number | K011775 |
Product Classification |
Neurological stereotaxic Instrument - Product Code HAW
|
Product | microTargeting" Drive System, Product Number MT-DS-01 |
Code Information |
UDI: 00873263003503 |
Recalling Firm/ Manufacturer |
FHC, Inc. 1201 Main St Bowdoin ME 04287-7302
|
For Additional Information Contact | Kelly Moeykens 207-666-5425 |
Manufacturer 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. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = HAW
|
|
|
|