The Recall Desk
LowFDA (Devices)·Z-1285-2016·Announced 2016-04-06

Ossur Recalls Knee Shields and Medical Devices Due to Packaging Defect

Ossur Americas is recalling various medical devices, including knee shields and walkers, because the packaging is defective.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is due to a packaging defect, which falls under the 'packaging-only problems' criterion for a Low severity score.

Plain-English summary

Ossur Americas is recalling several medical devices, including the Knee Shield (Patella Cup), Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders, Extreme Custom, Unloader Custom, and Papoose Infant Spine Immobilizers. The recall is being conducted because the packaging for these products is defective.

The affected products were distributed in the United States to 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, and WV. The specific item number for the Knee Shield is B-250110000.

Consumers who have purchased these products should stop using them and contact the recalling firm for further instructions.

The recalled product

Product
Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the knee braces to provide protection from debris or impact to the patella while a patient participates in motocross activities.
Manufacturer
Ossur H / F
Affected units
7

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-250110000

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 →