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U.S. Department of Health and Human Services

Class 2 Device Recall Universal aluminum crutch

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  Class 2 Device Recall Universal aluminum crutch see related information
Date Initiated by Firm February 17, 2016
Create Date June 30, 2016
Recall Status1 Terminated 3 on June 13, 2018
Recall Number Z-2103-2016
Recall Event ID 73918
Product Classification Tips and pads, cane, crutch and walker - Product Code INP
Product Universal aluminum crutch, 1 pair per case

Aid the user in walking while relieving weight from one foot or leg.
Code Information Item #: RTL 10433
Recalling Firm/
Manufacturer
Medical Depot Inc.
99 Seaview Blvd Fl 2
Port Washington NY 11050-4606
For Additional Information Contact Jordan D. Marsh
516-998-4600 Ext. 4422
Manufacturer Reason
for Recall
Tip crutch failure involving the bottom of the metal portion which comes in contact with ground
FDA Determined
Cause 2
Nonconforming Material/Component
Action On February 17, 2016, drive DeVilbiss Healthcare issued a preliminary notice their customers informing them of the situation via courier service. Secondly, On February 25, 2016, drive DeVilbiss Healthcare distributed another notice informing customers that the potential issue was confirmed to a limited number of lots. Customers were advised to quarantine all products in inventory as replacement products will be provided. The company notified customers that they will commence shipping orders for the product on Monday, February 29, 2016. Customers were also advised that a substantial inventory of replacement crutch tips for distribution will begin on or about March 7, 2016. On March 11, 2016, drive DeVilbiss distributed a third notice to their customers via courier service advising them of customer reimbursement for time and labor costs associated with this action. Drive Devilbiss Healthcare will reimburse based on the total number of tips requested to be shipped. Lastly, on May 12, 2016, drive DeVilbiss distributed a fourth Urgent Medical Device notice and response form to their customers via email. drive DeVilbiss advised customers to: 1) quarantine any stock that has not been inspected already and compare serial numbers of stocks to list provided, 2) any product received after 3/7/16 has been fully inspected and has an approved crutch tip that is free of defect, 3) if products were further distributed, contact those customers who received product between 7/2015 to 12/2015 and determine if items are still being used, 4) If the customer is still using this item, contact your sales representative so the return and replacement of this product can be processed and 5) complete and return the response form vial email. Customers with questions can contact by telephone 516-998-4600 ext. 4422.
Quantity in Commerce 123,125 pairs
Distribution Nationwide Distribution
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.
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