medical Class II Updated 2019-03-20

Ossur Americas recalls Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TO

Recalled Product

Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML/MED; JT-400/ J TONG COMPONENT TRAY

Hazard / Issue

Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

Issued by

FDA

Affected States: HI, AL, CA, WA, AZ, TX, NM, NE, MI, IL, MN, MS, IN, OH, KY, TN, AK, UT, SC, NC, GA, PA, FL, NY, DE, RI, VA, MA

Lot/Code Info: All lots of the products manufactured from 06/30/2009 - 12/13/2018

View official government recall

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