Z-0196-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 31, 2018
- Initiation Date
- November 15, 2017
- Termination Date
- March 29, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 837 units
Product Description
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 Pattern
NC, ID, Belgium, Switzerland, Spain, Germany, Australia, France, Italy
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.