Ossur H / F: Medical Device Recall in 2016 - (Recall #: Z-1286-2016)

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 Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces.

Product Classification:

Class II

Date Initiated: February 24, 2016

Date Posted: April 6, 2016

Recall Number: Z-1286-2016

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: 456

Code Information:

Item No: B-250150201 B-250150202 B-250150203 B-250150204 B-250150205 B-250150206

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