Z-1041-2017 Class II Ongoing
FDA device recall Z-1041-2017 was initiated by Smith & Nephew, Inc. on Nov 11, 2016 and is designated Class II. Reason for recall: Lack of 510k clearance for design modification. The recall status is ongoing. Affected quantity: 15,960 units in the US.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 25, 2017
- Initiation Date
- Nov 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,960 units in the US
Product Description
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for chronic, acute, traumatic, subacute, and dehisced wounds/ulcers/partial thickness burns/flaps/grafts.
Reason for Recall
Lack of 510k clearance for design modification.
Distribution Pattern
Nationwide
Code Information
Model No. 66800164; All pumps of this model are affected.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1041-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026