FDA recall Z-0999-2019

Ossur Americas · Class II · device

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

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

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

Key facts

Status: Terminated
Initiation date: 2018-06-21
Report date: 2019-03-20
Termination date: 2020-09-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Foothill Ranch, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0999-2019