Ossur Recalls Multiple Orthopedic Braces and Medical Devices
Ossur Americas is recalling various orthopedic braces and medical devices due to unspecified product defects.
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 typically involves risk-of-harm products where injury has not yet been reported or temporary health consequences are possible.
Plain-English summary
Ossur Americas is recalling a wide range of orthopedic and medical devices, including the Unloader XT Extreme knee brace, Knee Shield, NecLoc Extrication Collar, Rebound walkers, and Papoose Infant Spine Immobilizers. The recall covers specific item numbers B-102500010, B-102500020, B-102600010, and B-102600020.
The recall was initiated because of a defect in the products, though the specific nature of the defect is not detailed in the provided source text. The agency has classified this as a Class II recall, indicating a situation where use of the product could cause temporary or medically reversible health consequences.
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 XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
- Manufacturer
- Ossur H / F
- Hazard
- Affected units
- 15
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-102500010 B-102500020 B-102600010 B-102600020
Distribution
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.
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