Ossur Americas Recall 88075
Description: OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101
Ossur Americas Recall 88075 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1896-2021 |
| Event ID | 88075 |
| Event Description | OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101 |
| Product Type | Devices |
| 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. |
| Quantity | 10,469 items |
| Recall 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. |
| Device Classification | 20210623 |
| Device Code Info | REF Number: MJS-101; MJSR-101. Lot Numbers: MX180425 through MX200306 |
| Center Classification Date | 20210617 |
| Recall Initiation Date | 20210601 |
| Recalling Firm | Ossur Americas |
| Initial Notification | Letter |
| Similar To |