Device product
OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101
Z-1896-2021
Product summary
- Firm
- Ossur Americas
- Event
- Event 88075
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,469 items
- Official record key
device-enforcement:Z-1896-2021
Official wording
Reason: 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.
Code information: REF Number: MJS-101; MJSR-101. Lot Numbers: MX180425 through MX200306
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.