FDAClass IIApril 27, 2016

Ossur Lil Angel Vest P2 Kodel. Pediatric recall

Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring…

Why was Ossur Lil Angel Vest P2 Kodel. Pediatric recalled?

There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

P/N: 545100K units from 2008 to current

Product
Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring…
Recalling firm
Ossur H / F
Quantity
435 total all models
Distribution
Distribution US Nationwide and Hong Kong
Recall date
April 27, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls