The Recall Desk
HighFDA (Devices)·Z-1295-2016·Announced 2016-04-06

Ossur Recalls Multiple Orthopedic Braces and Medical Devices

Ossur Americas is recalling various orthopedic braces and medical devices, including the Unloader Custom Lite, due to a defect described in the source text.

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, and the source text does not report any illnesses or injuries, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Ossur Americas is recalling a range of orthopedic and medical devices, including the Unloader Custom Lite, Knee Shield / Patella Cup, and NecLoc Extrication Collar. The Unloader Custom Lite is an external knee brace designed to provide support for knee instability caused by ligament injuries and osteoarthritis.

The recall was initiated because the product is defective, as stated in the source text. The specific nature of the defect is not detailed in the provided excerpt.

The affected units 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 with these products should stop using them and contact the manufacturer for instructions.

The recalled product

Product
Unloader Custom Lite Product Usage: Unloader Custom Lite 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 Braces
Hazard
Affected units
9

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-107500020 B-107600020

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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