FDA Medical Device Recalls (openFDA)
Ossur H / F: Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
- Recall number
- Z-1513-2016
- Recalling firm
- Ossur H / F
- Product
- Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
- Status
- Terminated
- Initiated
- 2016-03-14
- Posted
- not on file
- Terminated
- 2016-08-16
- Reason
- There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
- Root 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
- 435 total all models
- Distribution
- Distribution US Nationwide and Hong Kong
- Lot, serial or model codes
- P/N: 545150K units from 2008 to current
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KQZ
- Firm FEI
- 3003764610
- Firm city
- Reykjavik
- Firm state
- not on file
- Firm country
- Iceland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28