Medacta Usa Inc: Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.

Is my product affected?

Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.

• UPC 07630030803130
• UPC 07630030803154
• UPC 07630030803178
• UPC 07630030803192
• UPC 07630030803215
• UPC 07630030803239
• UPC 07630030803253
• UPC 07630030803277
• UPC 07630030803291
• UPC 07630030803147
• UPC 07630030803161
• UPC 07630030803185
• UPC 07630030803208
• UPC 07630030803222
• UPC 07630030803246
• UPC 07630030803260
• UPC 07630030803284
• UPC 07630030803307

Check against the official notice below — it lists the full affected range.

What happened

Medacta USA Inc is recalling the MiniMAX CEMENTLESS ANATOMICAL STEM, a device used in hip replacement surgery. The recall affects 837 units distributed across North Carolina, Idaho, Belgium, Switzerland, Spain, Germany, Australia, France, and Italy. The recall was triggered by monitoring that identified a trend of damaged packaging for this product.

The affected devices include multiple lot codes ranging from REF 01.13.100L through REF 01.13.108R, and all lots produced with the old version of the packaging with lot numbers less than 169041. The product record does not specify what action an affected consumer should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.

Details from the source

Reason for recall: Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem. Distribution: NC, ID, Belgium, Switzerland, Spain, Germany, Australia, France, Italy Quantity: 837 units Lot/code info: 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.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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