FDA-Device2018-05-02Class II
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Howmedica Osteonics Corp.
Hazard
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
Sold states
Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.
Affected count
6 units of catalog 5521-B-400
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1512-2018Don't want to check this manually?
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