Medacta Usa Inc recalls Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplast…

Recall date

November 15, 2017

Source

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

Recall number

Z-0196-2019

FDA classification

Class II

Brand / firm

Medacta Usa Inc

Sold / distributed

NC, ID, Belgium, Switzerland, Spain, Germany, Australia, France, Italy

Why it was recalled

Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.

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

What was recalled

Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.