Ossur H / F: Medical Device Recall in 2016 - (Recall #: Z-1285-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 24, 2016

Date Posted: April 6, 2016

Recall Number: Z-1285-2016

Event ID: 73380

Reason for Recall:

Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound Air Walker, Rebound Diabetic Walker, Back Support Suspenders Clip on Black, Back Support Suspenders Sew On Black, Extreme Custom, Unloader Custom XT, Unloader Custom Lite, Unloader Custom, and Papoose Infant Spine Immobilizers because the p

Status: Terminated

Product Quantity: 7

Code Information:

Item No: B-250110000

Distribution Pattern:

U.S. distribution to the following; 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

Voluntary or Mandated:

Voluntary: Firm initiated