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U.S. Department of Health and Human Services

Class 2 Device Recall Ossur Lil Angel Vest

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  Class 2 Device Recall Ossur Lil Angel Vest see related information
Date Initiated by Firm March 14, 2016
Create Date April 19, 2016
Recall Status1 Terminated 3 on August 16, 2016
Recall Number Z-1514-2016
Recall Event ID 73382
Product Classification Component, traction, non-invasive - Product Code KQZ
Product Ossur Lil Angel Vest P3 Lambswool. 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: 545150L 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 2
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.
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