Z-0986-2015 Class II Terminated
FDA device recall Z-0986-2015 was initiated by Stryker Instruments Div. Of Stryker Corporation on Jun 16, 2013 and is designated Class II. Reason for recall: Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure. The recall status is terminated (terminated Aug 20, 2015). Affected quantity: 3625.
Recall details
- Product Type
- Devices
- Report Date
- Jan 21, 2015
- Initiation Date
- Jun 16, 2013
- Termination Date
- Aug 20, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3625
Product description
The SurgiCounter Charging Cradle Product Usage: SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount Safety-Sponge System. The SurgiCount Safety-Sponge System is indicated for use in counting and recording the number of Safety-Sponge surgical sponges, laparotomy sponges, and towels used during surgical procedures.
Reason for recall
Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.
Distribution pattern
US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Code information
Part number: SC-0014 All lots at time of notice 6/16/2013
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0986-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026