Company: Stryker Instruments Div. of Stryker Corporation
Date of Enforcement Report 4/20/2016
Class lI:

PRODUCT

SurgiCounter” scanner Product Usage: The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges, and towels used during surgical procedures.
Recall Number Z-1379-2016

REASON
The affected SurgiCounter scanner does not correctly interact with the SC360 software. When docked pre/postoperatively, there is a potential for the affected SurgiCounter scanner to display an error message (code=2). Additionally, the SurgiCounter scanner software version number is not appropriately displayed in the SC360 application during installation.

RECALLING FIRM/MANUFACTURER
Stryker Instruments Div. of Stryker Corporation, Portage, MI on 3/1/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
286

DISTRIBUTION
Nationwide

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