Z-1896-2021 Class II Terminated
FDA device recall Z-1896-2021 was initiated by Ossur Americas on June 1, 2021 and is designated Class II. 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 motio… The recall status is terminated (terminated June 22, 2023). Affected quantity: 10,469 items.
Recall Details
- Product Type
- Devices
- Report Date
- June 23, 2021
- Initiation Date
- June 1, 2021
- Termination Date
- June 22, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,469 items
Product Description
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 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.
Code Information
REF Number: MJS-101; MJSR-101. Lot Numbers: MX180425 through MX200306