Howmedica Osteonics Corp.: Medical Device Recall in 2018 - (Recall #: Z-1512-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 12, 2018

Date Posted: May 2, 2018

Recall Number: Z-1512-2018

Event ID: 79661

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.

Status: Terminated

Product Quantity: 6 units of catalog 5521-B-400

Code Information:

Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated