Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
FDA Recall Z-1512-2016 · Posted None
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Recalling FirmOssur H / F
Recall StatusTerminated
Product CodeKQZ
Date Initiated2016-03-14
Date Terminated2016-08-16
Product Quantity435 total all models
Reason for Recall
There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Distribution US Nationwide and Hong Kong
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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