The Recall Desk
HighFDA (Devices)·Z-1290-2016·Announced 2016-04-06

Ossur Recalls Multiple Orthopedic Braces and Medical Devices

Ossur Americas is recalling various orthopedic braces and medical devices, including knee braces and back supports, due to a defect described as 'the p'.

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 indicates a risk of temporary or medically reversible health consequences. The source text does not report specific injuries or illnesses, placing this in the 'High' category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Ossur Americas is recalling a range of orthopedic and medical devices, including the Rebound Cartilage Custom knee brace, Knee Shield / Patella Cup, NecLoc Extrication Collar, and various back support suspenders. The recall also covers other products such as the Rebound Air Walker, Rebound Diabetic Walker, and Papoose Infant Spine Immobilizers.

The recall was initiated because the products are affected by a defect described in the source text as 'the p'. The specific nature of this defect is not fully detailed in the provided excerpt. The recalled 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 possess these products should stop using them and contact Ossur Americas for further instructions on how to proceed with the recall. The specific item numbers associated with the Rebound Cartilage Custom product are B-254500001, B-254600001, B-254700001, and B-254800001.

The recalled product

Product
Rebound Cartilage Custom Product Usage: Rebound Cartilage Custom is an external knee brace that provides support for knee instability due to ligament injuries and osteoarthritis.
Manufacturer
Ossur H / F
Category
Medical Device — Orthopedic Braces
Hazard
Affected units
24

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-254500001 B-254600001 B-254700001 B-254800001

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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