Ossur H / F: Medical Device Recall in 2016 - (Recall #: Z-1288-2016)

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:

Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.

Product Classification:

Class II

Date Initiated: February 24, 2016

Date Posted: April 6, 2016

Recall Number: Z-1288-2016

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: 15,825

Code Information:

Item No: MJ-200B MJ-200L MJ-200LFRT MJ-200S MJ-200SFRT MJ-250 MJ-250FRT MJ-2530 MJ-300 MJ-300FRT MJ-400 MJ-400FRT MJ-500 MJ-500FRT MJ-P2 MJ-P3 MJR-200L MJR-200S MJR-250 MJR-2530 MJR-300 MJR-400 MJR-500 MJR-P2 MJR-P3

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