Device product
Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Z-0380-2022
Product summary
- Firm
- Ossur Americas
- Event
- Event 89014
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-0380-2022
Official wording
Reason: Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
Code information: Instructions for Use Rev. 3 2018
Distribution pattern: US Nationwide distribution in the states of CA, NH, CT, RI, MA, FL, DE, NY, NJ, PA, OH, DC, MD, VA, NC, SC, GA, MS, LA, TN, TX, KY, IN, AZ, MI, WI, MN, IL, IA, MO, NE, MT, ID, CO, NM, WA, OR, NV, UT, KS, AK, VT, AR, OK, AL, SD, WV, PR.
Derived failure modes
-
Unknown
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.