Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall SurgiCounter Charging Cradle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall SurgiCounter Charging Cradle see related information
Date Initiated by Firm June 16, 2013
Date Posted January 15, 2015
Recall Status1 Terminated 3 on August 20, 2015
Recall Number Z-0986-2015
Recall Event ID 70093
510(K)Number K060076  
Product Classification Counter, sponge, surgical - Product Code LWH
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.
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 Contact Kelly 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
Action On 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 Commerce 3625
Distribution 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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LWH and Original Applicant = SURGICOUNT MEDICAL
-
-