The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1286-2016·Announced 2016-04-06

Ossur Recalls Multiple Medical Devices Including Knee Undersleeves and Walkers

Ossur Americas is recalling various medical devices, including knee undersleeves and walkers, due to a defect described in the source text.

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' category per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Ossur Americas is recalling a wide range of medical devices, including the Knee Undersleeve Gray, Knee Shield / Patella Cup, NecLoc Extrication Collar, Rebound Cartilage, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders, and various Unloader Custom braces. The recall also includes Papoose Infant Spine Immobilizers and Extreme Custom devices.

The source text indicates that these products are being recalled because of a defect, though the specific nature of the defect is not fully detailed in the provided excerpt. The recall involves 456 units of the Knee Undersleeve Gray, which are worn as an accessory for comfort under knee braces. These items were distributed across numerous U.S. states, including 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 who have purchased these products should stop using them and contact Ossur Americas for further instructions on how to return or dispose of the items. The recall number for this action is Z-1286-2016.

The recalled product

Product
Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces.
Manufacturer
Ossur H / F
Category
Medical Device — Orthopedic Devices
Hazard
Affected units
456

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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