Class 2 Device Recall Ossur Lil Angel Vest

• Date Initiated by Firm: March 14, 2016
• Create Date: April 19, 2016
• Recall Status: Terminated on August 16, 2016
• Recall Number: Z-1515-2016
• Recall Event ID: 73382
• Product Classification: Component, traction, non-invasive - Product Code KQZ
• Product: Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
• Code Information: P/N: 545150S units from 2008 to current
• Recalling Firm/ Manufacturer: Ossur H / F; Grjothals 5; Reykjavik Iceland
• For Additional Information Contact: Ossur Customer Service; 800-233-6263
• Manufacturer Reason for Recall: There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
• FDA Determined Cause: Component design/selection
• Action: Customer notification letter were sent on 03/14/16 via traceable method. The notification asked customers to examine their inventory, quarantine product subject to the recall and contact customer service for a return authorization to return the product to Ossur. Customers were asked to take the following actions: 1. Pass the notice to those who need to be aware within the organization or to any organization where the potentially affected devices have been transferred. 2. Maintain awareness on the notice for an appropriate period. 3. If have further distributed this product identify the customers and notify them at once of this product alert. It is recommended that a copy of the notice is included. 4. If any customers are currently wearing a product it is recommended a detailed inspection of the product vest structurebe conducted to ensure there is no visible cracks on the vest.
• Quantity in Commerce: 435 total all models
• Distribution: Distribution US Nationwide and Hong Kong
• 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.