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U.S. Department of Health and Human Services

Class 2 Device Recall SurgiCounter Charging Cradle

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 Class 2 Device Recall SurgiCounter Charging Cradlesee related information
Date Initiated by FirmJune 16, 2013
Date PostedJanuary 15, 2015
Recall Status1 Terminated 3 on August 20, 2015
Recall NumberZ-0986-2015
Recall Event ID 70093
510(K)NumberK060076 
Product Classification Counter, sponge, surgical - Product Code LWH
ProductThe 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.
Code Information Part number: SC-0014 All lots at time of notice 6/16/2013
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information ContactKelly Stalford
269-389-4321
Manufacturer Reason
for Recall		Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.
FDA Determined
Cause 2		Device Design
ActionOn 6/16/2013, Improvements to the SurgiCounter" charging base notifications were emailed to the affected users with instructions for requesting a replacement product. The notification included a description of the reason for the recall, affected product, and instructions for responding to the notification. For questions, call the Support team any time at (877) 520-2300 option 1, or support@scmd.com.
Quantity in Commerce3625
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LWH
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