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Recall Observatory FDA recall evidence

Device product

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.

Z-0986-2015

June 16, 2013

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 70093
Status
Terminated
Classification
Class II
Quantity
3625
Official record key
device-enforcement:Z-0986-2015

Official wording

Reason: Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.

Code information: Part number: SC-0014 All lots at time of notice 6/16/2013

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.