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

• Date Initiated by Firm: November 01, 2017
• Create Date: February 07, 2018
• Recall Status: Terminated 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
• FEI Number: 2110898
• 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: 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.