Ossur Americas Recall 89014
Description: Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Ossur Americas Recall 89014 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0380-2022 |
Event ID | 89014 |
Event Description | Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use |
Product Type | Devices |
Distribution | 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. |
Recall Reason | Instructions for use were updated to include additional information to facilitate the selection and use of the collar device. |
Device Classification | 20211222 |
Device Code Info | Instructions for Use Rev. 3 2018 |
Center Classification Date | 20211215 |
Recall Initiation Date | 20211109 |
Recalling Firm | Ossur Americas |
Initial Notification | Letter |
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