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U.S. Department of Health and Human Services

Class 2 Device Recall Restep DVT System

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 Class 2 Recall
Restep DVT System
see related information
Date Posted February 20, 2013
Recall Status1 Open
Recall Number Z-0840-2013
Recall Event ID 63692
Premarket Notification
510(K) Number
K090308 
Product Classification Sleeve, Limb, Compressible - Product Code JOW
Product STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 (AC Power Adaptor).
Code Information 108851407, 108851408, 108870192, 108874144, 108883271, 108886340, and 108888023.
Recalling Firm/
Manufacturer
Stryker Sustainability Solutions
1810 W Drake Dr
Tempe, Arizona 85283-4327
Consumer Instructions No consumer action necessary
For Additional Information Contact Moira Barton-Varty
888-888-3433 Ext. 5519
Manufacturer Reason
for Recall
Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Stryker Sustainability Solutions sent a Urgent Medical Device Removal Notification letter dated September 5, 2012, to all affected customers. The letter identified the product, problem and the action to be taken by the customer. The firm notified that affected AC Power Adaptors would be replaced with improved Adaptors. Any affected lots would be removed and shipped back to Stryker Sustainability Solutions for final disposition. Customers were instructed to fill out the attached Recall Effectiveness Form even if no affected product was found and fax to Stryker Sustainability Solutions at (480) 809-4957.
Quantity in Commerce 1,311
Distribution Distributed in Arizona and New Jersey.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JOW and Original Applicant = STORTFORD MEDICAL LLC
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