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U.S. Department of Health and Human Services

Class 2 Device Recall MiniMAX CEMENTLESS ANATOMICAL STEM

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  Class 2 Device Recall MiniMAX CEMENTLESS ANATOMICAL STEM see related information
Date Initiated by Firm November 15, 2017
Create Date October 19, 2018
Recall Status1 Terminated 3 on March 29, 2019
Recall Number Z-0196-2019
Recall Event ID 81090
510(K)Number K170845  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
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.
Recalling Firm/
Manufacturer		 Medacta Usa Inc
3973 Delp St
Memphis TN 38118-6110
For Additional Information Contact customer serivce
312-878-2381
Manufacturer Reason
for Recall		 Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.
FDA Determined
Cause 2		 Package design/selection
Action The firm initiated the recall by telephone to its distributors. The firm requested return of all recalled units.
Quantity in Commerce 837 units
Distribution NC, ID, Belgium, Switzerland, Spain, Germany, Australia, France, Italy
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LZO and Original Applicant = Medacta International SA
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