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Terminated

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

FDA Recall Z-0196-2019 · Posted None

Recalling FirmMedacta Usa Inc
Recall StatusTerminated
Product CodeLZO
Date Initiated2017-11-15
Date Terminated2019-03-29
Product Quantity837 units

Reason for Recall

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

Firm Action

The firm initiated the recall by telephone to its distributors. The firm requested return of all recalled units.

Root Cause

Package design/selection

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170845MiniMAXMedacta International S.A. · 2017-08-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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