Ossur Lil Angel Vest Recalled Due to Potential Plastic Strap Fracture
Ossur H / F is recalling Lil Angel Vest P2 Sorbatex pediatric vests because the plastic stabilizer strap may partially or completely fracture.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (fracture of a stabilizer strap) that poses a risk of harm to patients requiring cervical traction, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ossur H / F is recalling the Lil Angel Vest P2 Sorbatex, a pediatric-sized support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. The recall involves 435 units of all models, specifically P/N 545100S units manufactured from 2008 to the current date.
The recall is being conducted because there is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. The affected products were distributed nationwide in the United States and in Hong Kong.
Consumers should stop using the affected vests immediately. The source text does not provide specific instructions for consumers beyond the identification of the hazard, nor does it report any injuries or illnesses associated with the defect.
The recalled product
- Product
- 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.
- Manufacturer
- Ossur H / F
- Affected units
- 435
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- P/N: 545100S units from 2008 to current
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Ossur H / F under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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