FDA-Device2019-03-20Class II

Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ OB V2 RING KIT TI SM; 505400T/ CB RING KIT TI STD; 505400V2/ OB V2 RING KIT TI STD; 505500T/ CB RING KIT TI LG; 505500V2/ OB V2 RING KIT TI LG; 515300V2/ OB V2 RING KIT TI SM-No App; 515400V2/ OB V2 RING KIT TI STD-No App; 515500T/ CB RING KIT TI LG-No App; 515500V2/ OB V2 RING KIT TI LG-No App; 515300T/ CB RING KIT TI SM-No App; 515400T/ CB RING KIT TI STD-No App; 515301T/ CB RING KIT TI SM 8-No APP; 5153

Ossur Americas

Hazard

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.

Sold states

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

Affected count

182

Manufactured in

27051 Towne Centre Dr, N/A, Foothill Ranch, CA, United States

Products

Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2/ OB V2 RING KIT TI SM; 505400T/ CB RING KIT TI STD; 505400V2/ OB V2 RING KIT TI STD; 505500T/ CB RING KIT TI LG; 505500V2/ OB V2 RING KIT TI LG; 515300V2/ OB V2 RING KIT TI SM-No App; 515400V2/ OB V2 RING KIT TI STD-No App; 515500T/ CB RING KIT TI LG-No App; 515500V2/ OB V2 RING KIT TI LG-No App; 515300T/ CB RING KIT TI SM-No App; 515400T/ CB RING KIT TI STD-No App; 515301T/ CB RING KIT TI SM 8-No APP; 515301V2/ OB V2 RING KIT TI SM 8-No App; 515401T/ CB RING KIT TI STD 8-No APP; 515401V2/ OB V2 RING KIT TI STD 8-No APP; 515501T/ CB RING KIT TI LG 8-No App; 515501V2/ OB V2 RING KIT TI LG 8-No App; 540T/ STERILE TITANIUM COMP TRAY; 540V2/ STERILE V2 COMPONENT TRAY

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1001-2019

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