PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: March 21, 2018 Initiated: January 31, 2018 #Z-0946-2018

Product Description

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

Reason for Recall

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.

Details

Units Affected
162,348 units
Distribution
US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates
Location
Saint Paul, MN

Frequently Asked Questions

What product was recalled?
ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7. Recalled by 3M Company - Health Care Business. Units affected: 162,348 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 21, 2018. Severity: Moderate. Recall number: Z-0946-2018.