The Recall Desk
ModerateFDA (Devices)·Z-0196-2019·Announced 2018-10-31

Medacta MiniMAX Cementless Hip Stem Recalled for Packaging Breach

Medacta USA Inc. is recalling 837 units of MiniMAX Cementless Anatomical Stems because complaint monitoring identified a trend of packaging breaches.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves packaging integrity without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Medacta USA Inc. is recalling 837 units of the Medacta International MiniMAX Cementless Anatomical Stem, 12/14. These devices are intended for cementless use in total or partial hip arthroplasty in primary or revision surgery. The recall affects lots produced with the old version of the packaging, including lot numbers less than 169041.

The recall was initiated after complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem. The affected units were distributed in North Carolina, Idaho, Belgium, Switzerland, Spain, Germany, Australia, France, and Italy.

Consumers and healthcare providers should stop using the affected devices and contact Medacta USA Inc. for further instructions. The specific reference numbers and GTINs for the affected lots are listed in the official recall documentation.

The recalled product

Product
Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.
Manufacturer
Medacta Usa Inc
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
837

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distributed in 2 states:

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