Howmedica Osteonics Corp. recalls Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision to…

Recall date

January 12, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1512-2018

FDA classification

Class II

Brand / firm

Howmedica Osteonics Corp.

Sold / distributed

Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.

Why it was recalled

Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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