CLASS II Device recall · Reported 27 Apr 2016 · FDA Enforcement Report

Ossur Lil Angel Vest P3 Sorbatex recalled by Ossur H / F

Ossur H / F is recalling Ossur Lil Angel Vest P3 Sorbatex, distributed nationwide in the US. The recall was initiated on 14 Mar 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesP/N: 545150S units from 2008 to current

Quantity recalled435 total all models

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1515-2016
FDA event ID: 73382
Recalling firm: Ossur H / F, Reykjavik, N/A
Classification: Class II
Status: Terminated
Recall initiated: 14 Mar 2016
FDA classified: 19 Apr 2016
Reported: 27 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Spinal Implants

Timeline

14 Mar 2016	Recall initiated by company
19 Apr 2016	Classified by FDA	+36 days
27 Apr 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

Where it was distributed

Distribution US Nationwide and Hong Kong

Nationwide

Questions about this recall

Is Ossur Lil Angel Vest P3 Sorbatex recalled?

Yes. Ossur H / F recalled Ossur Lil Angel Vest P3 Sorbatex on 14 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1515-2016.

Why was it recalled?

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

Which lots are affected?

P/N: 545150S units from 2008 to current

Where was it sold?

Distribution US Nationwide and Hong Kong

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Ossur H / F

All 29

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9 Oct 2024Device	CLASS II	Miami J Select Collar recalled by Ossur H / F	Ossur H / F	Lead & Heavy Metals	39 states
22 May 2024Device	CLASS II	RKN130003, Rheo Knee 3 YR Warranty, MD, CE recalled by Ossur H / F	Ossur H / F	Other	Nationwide
22 May 2024Device	CLASS II	RKNXC0003, Rheo Knee XC 3 YR Warranty, MD, CE recalled by Ossur H / F	Ossur H / F	Other	Nationwide
22 May 2024Device	CLASS II	RKNXC0005, Rheo Knee XC 5 YR Warranty, MD, CE recalled by Ossur H / F	Ossur H / F	Other	Nationwide
22 May 2024Device	CLASS II	RKN130002, Rheo Knee 2 YR Warranty, MD, CE recalled by Ossur H / F	Ossur H / F	Other	Nationwide

Other Spinal Implants recalls

All 1,157

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9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	AVID Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide