Z-2106-2016Class II

Direct Supply aluminum crutch, adult, 1 pair per case Aid the user in walking while relieving weight from one...

Name: Z-2106-2016 Direct Supply aluminum crutch, adult, 1 pair per case Aid the user in walking while relieving weight from one...
Creator: Medical Depot Inc.
Published: 2016-02-17
License: https://open.fda.gov/license/

Medical Depot Inc. / initiated 2016-02-17 / Terminated / root cause: manufacturing process

FDA source

Medical Depot Inc. began a recall of Direct Supply aluminum crutch, adult, 1 pair per case Aid the user in walking while relieving weight from one foot or leg on 2016-02-17. FDA classified it as Class II and gives the reason as "Tip crutch failure involving the bottom of the metal portion which comes in contact with ground". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2106-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-17
Posted: 2016-06-30
Terminated: 2018-06-13
Recalling firm: Medical Depot Inc.
Product: Direct Supply aluminum crutch, adult, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.
Product code: INP Tips And Pads, Cane, Crutch And Walker
Reason for recall: Tip crutch failure involving the bottom of the metal portion which comes in contact with ground
Root cause tag: manufacturing process
FDA 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 in commerce: 123,125 pairs
Distribution: Nationwide Distribution
Product codes and lots: Item #: DS 10400

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2106-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2101-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30
Z-2102-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30
Z-2103-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30
Z-2104-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30
Z-2105-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30
Z-2106-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30

Product code INP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)