The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1298-2016·Announced 2016-04-06

Ossur Recalls Papoose Infant Spine Immobilizers and Other Medical Devices

Ossur Americas is recalling Papoose Infant Spine Immobilizers and other orthopedic devices due to a defect described as 'the p'.

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 is classified as FDA Class II, and the source text does not report any illnesses or injuries, placing it in the 'High' severity category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Ossur Americas is recalling the Papoose Infant Spine Immobilizer, along with several other orthopedic and mobility devices, including knee shields, walkers, and back supports. The recall is being conducted because of a defect described in the source text as 'the p'.

The affected Papoose Infant Spine Immobilizers include item numbers PA-100, PAR-100, PO-100, and POR-100. The recall covers 401 units with lot numbers ranging from MX140101 to MX150930. These devices are external class I orthotic devices used to secure the head and spine in proper anatomical alignment.

The products were distributed in the United States to the following states and districts: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, RI, TN, TX, UT, VA, VT, WA, WI, and WV. Consumers should stop using the affected devices and contact the manufacturer for further instructions.

The recalled product

Product
Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad Product Usage: The Papoose Infant Immobilizer is an external class I orthotic device used to…
Manufacturer
Ossur H / F
Category
Medical Device — Orthopedic / Spinal
Hazard
Affected units
401

Distribution

Distributed in 48 states:

Part of a larger recall action

This product is one of 14 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 14 products in this recall →

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