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U.S. Department of Health and Human Services

Class 2 Device Recall ACE(TM) BRAND, ULTRA LITE ANKLE brace

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  Class 2 Device Recall ACE(TM) BRAND, ULTRA LITE ANKLE brace see related information
Date Initiated by Firm November 01, 2017
Create Date February 07, 2018
Recall Status1 Terminated 3 on July 22, 2020
Recall Number Z-0552-2018
Recall Event ID 78444
Product Classification Splint, extremity, non-inflatable, external, non-sterile - Product Code NOC
Product ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9
Code Information (a) Cat #901014, Lot Numbers: 7223T2, 7133C2, 7144E2, 7332I2 (b) Cat #901015, Lot Number 7223U2
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
651-733-1110
Manufacturer Reason
for Recall
Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.
FDA Determined
Cause 2
Packaging process control
Action The firm initiated their recall on 11/01/2017 by letter. The letter requested the consignee cease distribution of the recalled product, isolate it pending return. Distributors were asked to notify their customers including a copy of the 3M recall notice.
Quantity in Commerce 996 units
Distribution AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MO, MS, NC, NH, NY, OH, OR, PA, SC, TN, TX, UT, VA, WI, WV
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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