Z-0946-2018 Class II Terminated
FDA device recall Z-0946-2018 was initiated by 3M Company - Health Care Business on Jan 31, 2018 and is designated Class II. 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… The recall status is terminated (terminated Feb 11, 2021). Affected quantity: 162,348 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 21, 2018
- Initiation Date
- Jan 31, 2018
- Termination Date
- Feb 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 162,348 units
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.
Distribution Pattern
US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates
Code Information
All lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0946-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026