FDA recall Z-0600-2018

Product

Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.

Reason for recall

Implant kit mislabeled

Distribution

US Distribution to the states of :CA and TX.

Key facts

Status

Terminated

Initiation date

2017-07-24

Report date

2018-02-21

Termination date

2019-02-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bedford, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0600-2018