FDA recall Z-1079-2019

Product

iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102

Reason for recall

The labeling of the boxes and sterile pouches did not match the contents.

Distribution

The products were distributed to the following US states: NH. The products were distributed to the following foreign countries: Germany

Key facts

Status

Terminated

Initiation date

2019-01-04

Report date

2019-04-10

Termination date

2020-06-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1079-2019