FDA recall Z-1896-2021

Product

OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101

Reason for recall

Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to increased range of motion in the cervical spine.

Distribution

U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Not provided.

Key facts

Status

Terminated

Initiation date

2021-06-01

Report date

2021-06-23

Termination date

2023-06-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Foothill Ranch, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1896-2021