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Howmedica Osteonics Corp. recalls Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision
Recalled May 2, 2018 · FDA recall Z-1512-2018 · Howmedica Osteonics
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. · FDA Class II
Units
6 units of catalog 5521-B-400
Sold at
Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.
Description
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
Product
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
Manufacturer(s)
Howmedica Osteonics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →