FDA-Device2018-05-02Class II
Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.
Howmedica Osteonics Corp.
Hazard
Customers may receive the incorrect size implant from what is labeled on the box.
Sold states
USA (nationwide) Distribution to the states of : AL, AZ, CA, FL, GA, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA
Affected count
77 total products
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1462-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief