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U.S. Department of Health and Human Services

Class 2 Device Recall ACE (TM) BRAND, DELUXE ANKLE BRACE

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  Class 2 Device Recall ACE (TM) BRAND, DELUXE ANKLE BRACE see related information
Date Initiated by Firm January 31, 2018
Create Date March 09, 2018
Recall Status1 Open3, Classified
Recall Number Z-0946-2018
Recall Event ID 79051
Product Classification Orthosis, limb brace - Product Code IQI
Product ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
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 Contact Erin 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
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 in Commerce 162,348 units
Distribution US and Australia, Jordan, Republic Of Korea, Lebanon, New Zealand, Oman, Qatar, Taiwan, United Arab Emirates
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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