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Recall Observatory FDA recall evidence

Device product

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

Z-0196-2019

November 15, 2017

Class II

Product summary

Firm
Medacta Usa Inc
Event
Event 81090
Status
Terminated
Classification
Class II
Quantity
837 units
Official record key
device-enforcement:Z-0196-2019

Official wording

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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