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Recall Observatory FDA recall evidence

Device product

Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, adult, 8 pairs per case, 3) Aluminum crutch, youth, 1 pair per case, 4) Aluminum crutch 8 pairs per case, 5) Aluminum crutch, tall adult, 1 pair per case & 6) Aluminum crutch, tall adult, 8 pairs per case

Z-2101-2016

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-2101-2016

Official wording

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

Code information: Item #.: 1) 10400-1, 2) 10400-8, 3) 10401-1, 4) 10401-8, 5) 10402-1 & 6) 10402-8

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