Class 2 Device Recall Unloader XT

• Date Initiated by Firm: February 24, 2016
• Create Date: March 31, 2016
• Recall Status: Terminated on August 15, 2016
• Recall Number: Z-1294-2016
• Recall Event ID: 73380
• Product Classification: Orthosis, limb brace - Product Code IQI
• Product: Unloader XT; ; Product Usage:; Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
• Code Information: Item No: B-102500010 B-102500020 B-102600010 B-102600020
• Recalling Firm/ Manufacturer: Ossur H / F; Grjothals 5; Reykjavik Iceland
• For Additional Information Contact: Ossur Customer Service; 800-2336263
• Manufacturer Reason for Recall: Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p
• FDA Determined Cause: Labeling False and Misleading
• Action: The firm sent out customer notification letters on 02/26/16. The notification letter instructed customers to include the latex caution notice in any existing inventory of affected products. The latex caution notice can be retrieved at the conclusion of the response survey or by going directly to safetyalerts.ossur.com. Should customers require ¿ssur to provide pre-printed notices for existing inventory, contact ¿ssur customer service. For the ¿ssur Miami J¿ Cervical Collars with lot numbers before MX150727 customers are instructed to remove and discard the assist strap, which contains natural rubber latex, located in the patient pack. Recipients of the notice with should take the following actions: 1. Pass the notice to those who need to be aware within the organization or to any organization where the affected devices have been transferred. 2. Maintain awareness on this notification for an appropriate period. 3. If have further distributed the products, identify customers and notify them at once of the product alert. It is recommended to include a copy of the alert notification letter. 4. If any of your customers are currently wearing a product, check for any skin irritations or other reactions consistent with natural rubber latex allergies. 5. To verify have received the notification, visit safetyalerts.ossur.com to complete the Response Survey. If any questions, contact ¿ssur Customer Service at (800) 233-6263. The notification letter for the Papoose Infant Spine Immobilizer contained the following additional actions/instructions: Examine inventory, quarantine products subject to the recall and contact customer service for a return authorization to return the product to ¿ssur. If any of customers are currently wearing a product, it is recommended replacing the unit with one shipped after the transition lot number MX150727. Check for any skin irritations or other reactions consistent with natural rubber latex allergies.
• Quantity in Commerce: 15
• Distribution: U.S. distribution to the following; AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, 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.