The Recall Desk
HighFDA (Devices)·Z-1296-2016·Announced 2016-04-06

Ossur Recalls Multiple Medical Devices Including Knee Braces and Walkers

Ossur Americas is recalling various medical devices, including knee braces and walkers, due to unspecified product issues.

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 is classified as FDA Class II, which indicates a situation where use of the product could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. This aligns with the 'High' severity rubric for risk-of-harm products where specific injury reports are not detailed in the provided text.

Plain-English summary

Ossur Americas is recalling a range of medical devices, including the Unloader Custom knee brace, Rebound walkers, and Papoose infant spine immobilizers. The recall includes specific item numbers B-122500020 and B-122600020 for the Unloader Custom product.

The recall was initiated because the product is subject to a Class II recall classification by the FDA. The source text does not specify the exact nature of the defect or the specific hazard associated with these devices.

The affected products 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 should stop using these products and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
Manufacturer
Ossur H / F
Category
Medical Device — Orthopedic and Mobility Aids
Hazard
Affected units
456

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)

  • Item No: B-122500020 B-122600020

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 →

Related recalls

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