Recall Z-1896-2021 ยท IQK Orthosis, Cervical
Ossur Americas
OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101
| Date | Jun 1, 2021 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | On 06/01/2021, the Recalling Firm emailed or called its customers and provided an "URGENT MEDICAL DEVICE RECALL" letter informing them that it had identified that cervical collars may deform under certain conditions, possibly leading to reduced immobilization of the cervical spine. The likelihood of deformation is higher when in use at higher height configurations. Further, the risk of deformation increases with the number of days the device is worn. Customers are instructed to: -Examine their inventory, quarantine products subject to the recall, and return the Customer Acknowledgement Form |
| Quantity | 10,469 items |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.