medical Class II Updated 2019-03-20

Ossur Americas recalls Ossur OB Resolve, Sterile, Part/ Description: 505300D/

Recalled Product

Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML; 505400D/ OB RESOLVE RING KIT STD; 505500D/ OB RESOLVE RING KIT LRG; 515300D/ OB RESOLVE RING KIT SM-No App; 515400D/ OB RESOLVE RING KIT STD-No App; 515500D/ OB RESOLVE RING KIT LG-No App; 540D/ OB RESOLVE 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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