FDA Medical Device Recalls (openFDA)
3M Company - Health Care Business: ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
- Recall number
- Z-0946-2018
- Recalling firm
- 3M Company - Health Care Business
- Product
- ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
- Status
- Terminated
- Initiated
- 2018-01-31
- Posted
- not on file
- Terminated
- 2021-02-11
- 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.
- Root cause
- Error in labeling
- Action
- The firm initiated their recall by letter on 01/30/2018. The letter stated the following: "Actions required: 1. Immediately discontinue sale of Futuro" Quick Strap Ankle Brace. 2. Isolate or quarantine any stock of the Futuro" Quick Strap Ankle Brace. 3. Call 1-866-746-2524, option #2, Monday to Friday, 8:00 am 4:30 pm Central time, to arrange for the return of the Futuro" Quick Strap Ankle Brace, Cat# 47736EN. 4. If you have further distributed the Futuro" Quick Strap Ankle Brace, please notify any of your customers at once. Please include a copy of this letter in your communications. We apologize for any inconvenience this may cause you. Should you have any questions regarding the product and return process, please feel free to contact 3M Customer Service at 1-866-746-2524, option 2, Monday to Friday, 8:00 am 4:30 pm Central Time."
- Quantity
- 162,348 units
- Distribution
- US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates
- Lot, serial or model codes
- All lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IQI
- Firm FEI
- 2110898
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28