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U.S. Department of Health and Human Services

Class 2 Device Recall FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT

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 Class 2 Device Recall FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORTsee related information
Date Initiated by FirmJanuary 31, 2018
Create DateMarch 09, 2018
Recall Status1 Terminated 3 on February 11, 2021
Recall NumberZ-0945-2018
Recall Event ID 79051
Product Classification Orthosis, limb brace - Product Code IQI
ProductFUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6
Code Information All lots
Recalling Firm/
Manufacturer		 3M Company - Health Care Business
3m Center 2510 Conway Ave , B# 275-5-W-6
Saint Paul MN 55144-0001
For Additional Information ContactErin Bix
651-736-2406
Manufacturer 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.
FDA Determined
Cause 2		Error in labeling
ActionThe 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 in Commerce158,179 units
DistributionUS and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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