The Recall Desk
HighFDA (Devices)·Z-1291-2016·Announced 2016-04-06

Ossur Recalls Rebound Air Walkers and Other Medical Devices

Ossur Americas is recalling Rebound Air Walkers and other medical devices 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. The source text does not report specific injuries or illnesses, but the products are medical devices used for injury stabilization and rehabilitation, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Ossur Americas is recalling a variety of medical devices, including Rebound Air Walkers, Knee Shield / Patella Cup, and NecLoc Extrication Collars. The recall notice states that these products are being recalled because of a defect described in the source text as 'the p'.

The Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative use, and trauma or rehab use. The recall covers 7,623 units of the Rebound Air Walker product. Distribution was to the U.S. in the following states and districts: 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, WV.

Consumers should stop using the affected products and contact the manufacturer for instructions on return or replacement. The specific item numbers for the Rebound Air Walker include B-242900001 through B-242900065, with variations ending in E and SE.

The recalled product

Product
Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative use, and trauma or rehab use.
Manufacturer
Ossur H / F
Affected units
7,623

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.

See all 14 products in this recall →