Events

Recall of Device Recall SurgiCounter scanner part of the SurgiCount SafetySponge System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. of Stryker Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73595
  • Event Risk Class
    Class 2
  • Event Number
    Z-1379-2016
  • Event Initiated Date
    2016-03-21
  • Event Date Posted
    2016-04-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144552
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Counter, sponge, surgical - Product Code LWH
  • Reason
    The affected scanner does not correctly interact with the sc360 software. when docked pre/postoperatively, the affected surgicounter scanner may display an error message (code=2). also, the surgicounter scanner software version number is not appropriately displayed in the sc360 application during installation.
  • Action
    Stryker sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letters dated March 21, 2016 to affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments: Kelly Jo Davis 269-389-2921 kellyjo.davis@stryker.com

Device

Device Recall SurgiCounter scanner part of the SurgiCount SafetySponge System
  • Model / Serial
    Model Number(s):  0694-097-000 0694-097-001  Units individually serialized, SN numbers included in recall Letter.  Units distributed 11/1/2015-12/17/2015  Stryker Product Number: 0694097000 Serial# 1525901643  1526602693  1526603463  1526708353  1531400083  1531400453  1531400823 1525901653  1526602713  1526603473  1526708393  1531400093  1531400463  1531400833 1525901663  1526602723  1526603483  1526708403  1531400103  1531400473  1531400843 1525901673  1526602733  1526603493  1526708413  1531400113  1531400483  1531400853 1525901683  1526602743  1526603503  1526708423  1531400123  1531400493  1531400863 1525901693  1526602753  1526603513  1526708443  1531400133  1531400503  1531400873 1525901703  1526602863  1526603523  1526708463  1531400143  1531400513  1531400883 1525901713  1526602873  1526603533  1526708473  1531400153  1531400523  1531400893 1525901723  1526602883  1526603543  1526708493  1531400163  1531400533  1531400903 1525901733  1526602893  1526603553  1526708503  1531400173  1531400543  1531400913 1526106133  1526602903  1526603563  1526708523  1531400183  1531400553  1531400923 1526106143  1526602913  1526603573  1526708533  1531400193  1531400563  1531400933 1526106153  1526602923  1526603583  1526708543  1531400203  1531400573  1531400943 1526106163  1526602933  1526603593  1526708563  1531400213  1531400583  1531400953 1526106173  1526602943  1526603603  1526708573  1531400223  1531400593  1531400963 1526106183  1526602953  1526603613  1526708583  1531400233  1531400603  1531400973 1526106193  1526602963  1526603623  1527101333  1531400243  1531400613  1531400983 1526106203  1526602973  1526603633  1527207393  1531400253  1531400623  1531400993 1526106213  1526602983  1526603643  1527207413  1531400263  1531400633  1531401003 1526106223  1526602993  1526603653  1527207523  1531400273  1531400643  1531503063 1526106233  1526603003  1526708093  1527402703  1531400283  1531400653  1531503073 1526106243  1526603013  1526708103  1527402723  1531400293  1531400663  1531503083 1526106293  1526603023  1526708113  1527402733  1531400303  1531400673  1531503093 1526106303  1526603033  1526708123  1527402743  1531400313  1531400683  1531503103 1526106313  1526603043  1526708133  1527402753  1531400323  1531400693  1531503113 1526106343  1526603053  1526708193  1527402763  1531400333  1531400703  1531503123 1526106363  1526603063  1526708203  1527402833  1531400343  1531400713  1531503133 1526106373  1526603073  1526708213  1527408173  1531400353  1531400723  1531503143 1526106423  1526603083  1526708223  1527408183  1531400363  1531400733  1531503153 1526106433  1526603093  1526708233  1527408193  1531400373  1531400743  1531503173 1526106493  1526603103  1526708253  1527408203  1531400383  1531400753  1531503183 1526106503  1526603113  1526708263  1531400023  1531400393  1531400763  1531503193 1526106513  1526603123  1526708283  1531400033  1531400403  1531400773  1531503203 1526106523  1526603133  1526708303  1531400043  1531400413  1531400783  1531503213 1526106583  1526603143  1526708313  1531400053  1531400423  1531400793  1531503233 1526602673  1526603153  1526708333  1531400063  1531400433  1531400803  1531503323 1526602683  1526603383  1526708343  1531400073  1531400443  1531400813  Stryker Product Number: 0694097001 Serial# 1533400133 1533400203 1532305563 1526809553 1531504263 1531504303 1531504293 1532305603 1532305583 1533400153 1533400173 1532305593 1527501963 1527502033 1527501973 1527502013 1533400143 1526809513 1526809523 1526809533 1526809543 1527501943 1527501983 1527502023 1531504273 1531504283 1527501953 1532305573
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of AR, AZ, CA, CT, FL, GA, IN, LA, MD, MN, MO, MS, NJ, NM, NY, OH, SC, SD, TN, TX and UT.
  • Product Description
    SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. || Model numbers 0694-097-000 and 0694-097-001. || 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.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA