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Recall Observatory FDA recall evidence

Device product

OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101

Z-1896-2021

June 01, 2021

Class II

Product summary

Firm
Ossur Americas
Event
Event 88075
Status
Terminated
Classification
Class II
Quantity
10,469 items
Official record key
device-enforcement:Z-1896-2021

Official wording

Reason: 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.

Code information: REF Number: MJS-101; MJSR-101. Lot Numbers: MX180425 through MX200306

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.