medical Class II Updated 2019-03-20

Ossur Americas recalls Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ R

Recalled Product

Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel; 545700L/ ReSolve Halo Vest-shrt lmbwool; 545800K/ ReSolve Halo Vest-tall kodel; 545800L/ ReSolve Halo Vest-tall lmbwool

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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