The Recall Desk
HighFDA (Devices)·Z-1293-2016·Announced 2016-04-06

Ossur Recalls Multiple Medical Devices Including Back Support Suspenders

Ossur Americas is recalling various medical devices, including back support suspenders, 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, which typically involves a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report specific injuries or deaths, and the defect description is incomplete, 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 range of medical devices, including Back Support Suspenders (Clip on Black and Sew On Black), Knee Shields, NecLoc Extrication Collars, Rebound walkers, and Papoose Infant Spine Immobilizers. The recall includes specific item numbers 10912 and 10913 for the back support suspenders.

The source text indicates the recall is occurring because of a defect, though the specific nature of the defect is cut off in the provided text. The agency classification for this recall is Class II.

The 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 the affected products and contact the manufacturer for instructions.

The recalled product

Product
Back Support Suspenders Clip on Black Back Support Suspenders Sew on Black
Manufacturer
Ossur H / F
Category
Medical Device — Orthopedic / Mobility Aids
Hazard
Affected units
2

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: 10912 10913

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 →

Related recalls

Same manufacturer · Ossur H / F

See all →

Same hazard · defect

See all →