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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0380-2022
Event ID89014
Event DescriptionMiami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Product TypeDevices
DistributionUS 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 ReasonInstructions for use were updated to include additional information to facilitate the selection and use of the collar device.
Device Classification20211222
Device Code InfoInstructions for Use Rev. 3 2018
Center Classification Date20211215
Recall Initiation Date20211109
Recalling FirmOssur Americas
Initial Notification Letter
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