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Recall Observatory FDA recall evidence

Device product

ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7

Z-0946-2018

January 31, 2018

Class II

Product summary

Firm
3M Company - Health Care Business
Event
Event 79051
Status
Terminated
Classification
Class II
Quantity
162,348 units
Official record key
device-enforcement:Z-0946-2018

Official wording

Reason: 3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natural latex rubber, but do not include the appropriate caution statement.

Code information: All lots

Distribution pattern: US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natural latex rubber, but do not include the appropriate caution statement.