Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM — Class II medical device recall Z-0196-2019
Terminated recall by Medacta Usa Inc, reported 2018-10-31, distributed in ID, NC. Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.
| Recall number | Z-0196-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medacta Usa Inc, Memphis, TN, United States |
| Recall initiated | 2017-11-15 |
| Classified | 2018-10-19 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2019-03-29 |
| Distributed | ID, NC |
| Countries outside the US | AU, BE, CH, DE, ES, FR, IT |
| Quantity | 837 units |
| UPC / GTIN / UDI-DI | 07630030803130, 07630030803147, 07630030803154, 07630030803161, 07630030803178, 07630030803185, 07630030803192, 07630030803208, 07630030803215, 07630030803222, 07630030803239, 07630030803246, 07630030803253, 07630030803260, 07630030803277, 07630030803284, 07630030803291, 07630030803307 |
| Model numbers | 01.13.100L, 01.13.100R, 01.13.101L, 01.13.101R, 01.13.102L, 01.13.102R, 01.13.103L, 01.13.103R, 01.13.104L, 01.13.104R, 01.13.105L, 01.13.105R, 01.13.106L, 01.13.106R, 01.13.107L, 01.13.107R, 01.13.108L, 01.13.108R |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0196-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.