FDA recall Z-0196-2019

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2017-11-15

Report date

2018-10-31

Termination date

2019-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0196-2019