Z-0999-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 20, 2019
- Initiation Date
- June 21, 2018
- Termination Date
- September 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 342
Product Description
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
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.
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
Code Information
All lots of the products manufactured from 06/30/2009 - 12/13/2018