Reported Oct 31, 2018 · Terminated

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

Medacta USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medacta Usa Inc · 3973 Delp St · Memphis, TN · 38118-6110

Is this the product you have?

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

18 of 18 products

Products covered by this recall
Model / numberProduct as published
07630030803130REF 01.13.100L
07630030803154REF 01.13.101L
07630030803178REF 01.13.102L
07630030803192REF 01.13.103L
07630030803215REF 01.13.104L
07630030803239REF 01.13.105L
07630030803253REF 01.13.106L
07630030803277REF 01.13.107L
07630030803291REF 01.13.108L
07630030803147REF 01.13.100R
07630030803161REF 01.13.101R
07630030803185REF 01.13.102R
07630030803208REF 01.13.103R
07630030803222REF 01.13.104R
07630030803246REF 01.13.105R
07630030803260REF 01.13.106R
07630030803284REF 01.13.107R
07630030803307REF 01.13.108R, Lots produced with the old version of the packaging, including lot numbers less than 169041.
Amount recalled
837 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 29, 2019 · Data as of Sep 19, 5:37 PM UTC

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