Medical device recalls Moderate risk

3M Company - Health Care Business recalls ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7

Recall date
January 31, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0946-2018
FDA classification
Class II
Brand / firm
3M Company - Health Care Business
Sold / distributed
US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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