The Recall Desk
HighFDA (Devices)·Z-1510-2016·Announced 2016-04-27

Ossur Lil Angel Vest P2 Kodel Recalled for Potential Plastic Strap Fracture

Ossur H / F is recalling 435 Lil Angel Vest P2 Kodel units due to a potential for partial or complete fracture of the plastic stabilizer strap.

What this means for you

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 that could lead to injury, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Ossur H / F is recalling 435 units of the Lil Angel Vest P2 Kodel, a pediatric-sized support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. The recall covers units with part number 545100K manufactured from 2008 to the current date.

The recall is being issued 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 and contact the recalling firm for further instructions.

The recalled product

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 traction along the cervical spine.
Manufacturer
Ossur H / F
Category
Medical Device — Orthopedic / Cervical Traction
Hazard
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: 545100K 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.

See all 6 products in this recall →

Related recalls

Same manufacturer · Ossur H / F

See all →

Same hazard · structural failure

See all →