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Recall Observatory FDA recall evidence

Device product

Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box

Z-2475-2020

June 18, 2020

Class II

Product summary

Firm
Mueller Sports Medicine, Inc
Event
Event 85884
Status
Terminated
Classification
Class II
Quantity
135,354 units
Official record key
device-enforcement:Z-2475-2020

Official wording

Reason: Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex".

Code information: Reference number: 64217, UPC number: 074676642178

Distribution pattern: U.S. distribution only: AR and OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Natural rubber is present in Hybrid Wraparound Knee Support labeled as "Not made with Natural Rubber latex".