The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1292-2016·Announced 2016-04-06

Ossur Recalls Rebound Diabetic Walkers and Other Medical Devices

Ossur Americas is recalling Rebound Diabetic Walkers and other medical devices due to a defect described as 'the p'.

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 for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Ossur Americas is recalling a variety of medical devices, including Rebound Diabetic Walkers, Knee Shields, and Spine Immobilizers. The recall notice indicates that these products are being recalled because of a defect described in the source text as 'the p'.

The Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers. The recall covers 34 units 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 these products should stop using them and contact the manufacturer for further instructions. The specific item numbers for the recalled Rebound Diabetic Walkers are B-242500002, B-242500003, B-242500004, and B-242500005.

The recalled product

Product
Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers.
Manufacturer
Ossur H / F
Category
Medical Device — Orthopedic / Mobility
Hazard
Affected units
34

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-242500002 B-242500003 B-242500004 B-242500005

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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