Ossur Americas: Medical Device Recall in 2021 - (Recall #: Z-0380-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 9, 2021

Date Posted: December 22, 2021

Recall Number: Z-0380-2022

Event ID: 89014

Reason for Recall:

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

Status: Terminated

Product Quantity:

Code Information:

Instructions for Use Rev. 3 2018

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated