Ossur Americas recalls Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use

Recall date

November 9, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0380-2022

FDA classification

Class II

Brand / firm

Ossur Americas

Sold / distributed

US Nationwide distribution in the states of CA, NH, CT, RI, MA, FL, DE, NY, NJ, PA, OH, DC, MD, VA, NC, SC, GA, MS, LA, TN, TX, KY, IN, AZ, MI, WI, MN, IL, IA, MO, NE, MT, ID, CO, NM, WA, OR, NV, UT, KS, AK, VT, AR, OK, AL, SD, WV, PR.

Why it was recalled

Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use