FDA recall Z-1512-2018

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-01-12

Report date

2018-05-02

Termination date

2020-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1512-2018