MiniMAX Stems recallZ-0196-2019 · Medacta Usa Inc · initiated Nov 15, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medacta Usa Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.
FDA root cause category: Package design/selection
What the company is doing
The firm initiated the recall by telephone to its distributors. The firm requested return of all recalled units.
Recall details
- Recall number
- Z-0196-2019
- Status
- Terminated
- Initiated by the company
- Nov 15, 2017
- Recalling firm
- Medacta Usa Inc
- Quantity
- 837 units
- Product code
- LZO
- FDA submissions
- K170845
- Distribution
- NC, ID, Belgium, Switzerland, Spain, Germany, Australia, France, Italy
Product description
Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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.
Devices named in this recall
18 devices in the FDA device registry whose identifier appears in the recall's code information.
- MiniMAX Stems 01.13.105LMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall8 reports
- MiniMAX Stems 01.13.104LMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall6 reports
- MiniMAX Stems 01.13.106RMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall6 reports
- MiniMAX Stems 01.13.103RMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall5 reports
- MiniMAX Stems 01.13.105RMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall5 reports
- MiniMAX Stems 01.13.102RMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall4 reports
- MiniMAX Stems 01.13.104RMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall4 reports
- MiniMAX Stems 01.13.106LMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall4 reports
- MiniMAX Stems 01.13.102LMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall2 reports
- MiniMAX Stems 01.13.103LMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall2 reports
- MiniMAX Stems 01.13.107LMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall2 reports
- MiniMAX Stems 01.13.108LMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall2 reports
- MiniMAX Stems 01.13.108RMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall2 reports
- MiniMAX Stems 01.13.100LMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall0 reports
- MiniMAX Stems 01.13.100RMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall0 reports
- MiniMAX Stems 01.13.101LMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall0 reports
- MiniMAX Stems 01.13.101RMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall0 reports
- MiniMAX Stems 01.13.107RMedacta International SA · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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