StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for
FDA device recall Z-2930-2020 · posted 2020-09-02 · Open, Classified
Recall details
- Recalling firm
- Stimwave Technologies Inc
- Reason for recall
- The product contains a non-functional component not referenced in product labeling.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- GZF
- Quantity affected
- 1424 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, O
- Date initiated
- 2020-07-15
- Date posted
- 2020-09-02
- Location
- Pompano Beach, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit (K171366) | Stimwave Technologies Inc., Dba Stimq, LLC | 2017-08-04 |
| StimQ Peripheral Nerve Stimulator (PNS) System (K152178) | Stimq, LLC | 2016-03-11 |