FDA recall Z-2967-2018

Product

Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.

Reason for recall

After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.

Distribution

U.S. Distribution to states of: AZ, MO, MS, NY, OK, and UT; internationally to: Japan.

Key facts

Status

Terminated

Initiation date

2018-05-14

Report date

2018-09-12

Termination date

2020-08-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2967-2018