Ossur H / F: Medical Device Recall in 2016 - (Recall #: Z-1294-2016)

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:

Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.

Product Classification:

Class II

Date Initiated: February 24, 2016

Date Posted: April 6, 2016

Recall Number: Z-1294-2016

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: 15

Code Information:

Item No: B-102500010 B-102500020 B-102600010 B-102600020

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