Recall Z-2932-2020 ยท GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Stimwave Technologies Inc
StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to th
| Date | Sep 2, 2020 (initiated Jul 15, 2020) |
| Status | Open, Classified |
| Reason | The product contains a non-functional component not referenced in product labeling. |
| Root cause | Under Investigation by firm |
| Action | Field Safety Correction/Advisory Notices were sent to Distributors, Regional Sales Directors, and Territory Managers via email on 07/15/2020, describing the issue, recall instructions and their responsibilities. Prior to this communication, these parties received training on 07/13/2020 on the field action activities identifying the issue, instructions, and their responsibilities as explained in the letter. A physician letter was issued on 08/06/2020 to inform physicians of the recall. |
| Quantity | 2197 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, KS, LA, MD, MO, MI, MN, MA, MS, NC, NM, ND, NV, NY, NE, NJ, OK, OH, OR, PR, PA, RI, SC, TN, TX, UT, VA, WA, WI and the countries of The Netherlands, Belgium, Sl |
| FDA record | Open on fda.gov |