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Recall Observatory FDA recall evidence

Device product

Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use

Z-0380-2022

November 09, 2021

Class II

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

    reason.no_named_rule · v1.0.0

    Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.