Medacta Usa Inc: Medical Device Recall in 2018 - (Recall #: Z-0196-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 15, 2017

Date Posted: October 31, 2018

Recall Number: Z-0196-2019

Event ID: 81090

Reason for Recall:

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

Status: Terminated

Product Quantity: 837 units

Code Information:

a) REF 01.13.100L, GTIN 07630030803130 b) REF 01.13.101L, GTIN 07630030803154 c) REF 01.13.102L, GTIN 07630030803178 d) REF 01.13.103L, GTIN 07630030803192 e) REF 01.13.104L, GTIN 07630030803215 f) REF 01.13.105L, GTIN 07630030803239 g) REF 01.13.106L, GTIN 07630030803253 h) REF 01.13.107L, GTIN 07630030803277 I) REF 01.13.108L, GTIN 07630030803291 j) REF 01.13.100R, GTIN 07630030803147 k) REF 01.13.101R, GTIN 07630030803161 l) REF 01.13.102R, GTIN 07630030803185 m) REF 01.13.103R, GTIN 07630030803208 n) REF 01.13.104R, GTIN 07630030803222 o) REF 01.13.105R, GTIN 07630030803246 p) REF 01.13.106R, GTIN 07630030803260 q) REF 01.13.107R, GTIN 07630030803284 r) REF 01.13.108R, GTIN 07630030803307 Lots produced with the old version of the packaging, including lot numbers less than 169041.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated