Recall Z-0946-2018— 3M Company - Health Care Business
Class II · Terminated
Class II FDA medical device recall by 3M Company - Health Care Business, initiated 2018-01-31, terminated 2021-02-11. FDA's recall record names no specific 510(k) clearance for this event. Product: ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7. 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..
- Recalling firm
- 3M Company - Health Care Business
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-31
- Terminated
- 2021-02-11
- Firm location
- Saint Paul, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.