Z-2062-2015 Class II Terminated
FDA device recall Z-2062-2015 was initiated by Stryker Instruments Div. Of Stryker Corporation on May 8, 2015 and is designated Class II. Reason for recall: Potential sterility breach in the packaging. The recall status is terminated (terminated Oct 19, 2015). Affected quantity: 5,328 each (444 boxes).
Recall details
- Product Type
- Devices
- Report Date
- Jul 22, 2015
- Initiation Date
- May 8, 2015
- Termination Date
- Oct 19, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,328 each (444 boxes)
Product description
0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.
Reason for recall
Potential sterility breach in the packaging.
Distribution pattern
Nationwide Distribution-including the states of FL, IA, IL, IN, LA, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WI.
Code information
0210-312-000: 12138012, 12203012, 12229012, 12256012, 12293012, 12314012, 12338012, 13086012, 13140012, 13192012; 0210-318-000: 14140012,14258012; 0210-318-100: 12294012,13051012; 0210-318-200: 12143012, 12293012, 13066012, 14037012, 14112012
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2062-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026