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U.S. Department of Health and Human Services

Class 2 Device Recall Crocodile

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  Class 2 Device Recall Crocodile see related information
Date Initiated by Firm August 26, 2013
Date Posted December 16, 2014
Recall Status1 Terminated 3 on December 04, 2017
Recall Number Z-0503-2015
Recall Event ID 69665
510(K)Number K934560  
Product Classification Wheelchair, mechanical - Product Code IOR
Product Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities.
Product Usage:
The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and can be used for children between the ages of 2 to 18 years.
Code Information GMDN code; 31119
Recalling Firm/
Manufacturer		 Snug Seat Inc
12801 E Independence Blvd
Matthews NC 28105-4968
For Additional Information Contact Kirk MacKenzie
704-882-0668
Manufacturer Reason
for Recall		 The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to dislodge.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An Urgent Field Safety Notice letter dated August 26, 2013 and September 17, 2013 was sent to customers. The letter identified the affected product, problem and actions to be taken. New replacement bolts were provided to customers.
Quantity in Commerce 726 units
Distribution Worldwide Distribution - U.S. Nationwide in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA & WV; International: Australia, Canada, China, Denmark, Estonia, Finland, France, Germany, Greece, Italy, Japan, New Zealand, Poland, Russia, Spain, The Netherlands, and The UK
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 = IOR and Original Applicant = SNUG SEAT, INC.
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