Total Knee Replacement recalled over labeling errors

Recall date

July 24, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

ConforMIS, Inc. recalls Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS111111102…

Recall number

Z-0600-2018

FDA classification

Class II

Brand / firm

ConforMIS, Inc.

Sold / distributed

US Distribution to the states of :CA and TX.

Why it was recalled

Implant kit mislabeled

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.