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Recall Observatory FDA recall evidence

Device product

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

Z-2106-2016

February 17, 2016

Class II

Product summary

Firm
Medical Depot Inc.
Event
Event 73918
Status
Terminated
Classification
Class II
Quantity
123,125 pairs
Official record key
device-enforcement:Z-2106-2016

Official wording

Reason: Tip crutch failure involving the bottom of the metal portion which comes in contact with ground

Code information: Item #: DS 10400

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Tip crutch failure involving the bottom of the metal portion which comes in contact with ground