Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ossur CB Resolve Recalled by Ossur Americas Due to Halo system products labeled MR conditional will undergo...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ossur Americas directly.
Affected Products
Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERILE UNIT SML; 505400C/ CB RESOLVE STERILE UNIT STD; 505500C/ CB Resolve Sterile Unit LRG; 515300C/ CB RESOLVE RING KIT SM-No App; 515400C/ CB RESOLVE RING KIT STD-No App; 515500C/ CB RESOLVE RING KIT LG-No App; 540C/ CB RESOLVE COMPONENT TRAY; 553CB/ CB RING TRAY SM; 554CB/ CB RING TRAY STD; 555CB/ CB RING TRAY LG; 505301C/ Kit Closed Back Halo Sm; 505401C/ Kit Closed Back Halo Md; 505501C/ Kit Closed Back Halo Lg
Quantity: 656
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 28 states: AL, AK, AZ, CA, DE, FL, GA, HI, IL, IN, KY, MA, MI, MN, MS, NE, NM, NY, NC, OH, PA, RI, SC, TN, TX, UT, VA, WA
About Ossur Americas
Ossur Americas has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report