Ossur Americas: Medical Device Recall in 2019 - (Recall #: Z-1000-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 21, 2018

Date Posted: March 20, 2019

Recall Number: Z-1000-2019

Event ID: 80520

Reason for Recall:

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.

Status: Terminated

Product Quantity: 656

Code Information:

All lots of the products manufactured from 06/30/2009 - 12/13/2018

Distribution Pattern:

U.S.: HI, AL, CA, WA, AZ, TX, NM, NE, MI, IL, MN, MS, IN, OH, KY, TN, AK, AL, UT, SC, NC, GA, PA, FL, NY, DE, RI, VA, MA; Foreign: Australia, Germany, New Zealand, Belgium

Voluntary or Mandated:

Voluntary: Firm initiated