FDA Medical Device Recalls (openFDA)
Medical Depot Inc.: Universal aluminum crutch, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.
- Recall number
- Z-2103-2016
- Recalling firm
- Medical Depot Inc.
- Product
- Universal aluminum crutch, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.
- Status
- Terminated
- Initiated
- 2016-02-17
- Posted
- not on file
- Terminated
- 2018-06-13
- Reason
- Tip crutch failure involving the bottom of the metal portion which comes in contact with ground
- Root cause
- 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
- 123,125 pairs
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Item #: RTL 10433
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- INP
- Firm FEI
- 3002997602
- Firm city
- Port Washington
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28