Home / Recalls / Ossur Americas / Z-1896-2021

Z-1896-2021 Class II Terminated

Recalled by Ossur Americas — Foothill Ranch, CA

Recall Details

Product Type
Devices
Report Date
June 23, 2021
Initiation Date
June 1, 2021
Termination Date
June 22, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,469 items

Product Description

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

Reason for Recall

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.

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.

Code Information

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

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  • Z-0380-2022 Class II — Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR- (November 9, 2021)
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  • Z-1000-2019 Class II — Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE U (June 21, 2018)