The Recall Desk
ModerateFDA (Devices)·Z-1314-2021·Announced 2021-04-07

DePuy ATTUNE Knee Implant Recall for Damaged Packaging

DePuy Orthopaedics is recalling ATTUNE and MBT tibial base components used in knee replacements due to potential damaged packaging.

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, but the hazard is limited to potential damaged packaging with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling ATTUNE and MBT tibial base components used in Total Knee Arthroplasty. The recall involves 102 units distributed worldwide, including 6 units in the United States and 86 units in foreign countries. The affected components are designed for cemented applications.

The recall is being conducted due to potential damaged packaging. The source text does not report any illnesses, injuries, or deaths associated with these devices. The specific lots affected are identified by lot numbers 9558300, 9555958, 9554006, 9556397, 9558618, 9557992, 9558238, 9558239, and 9555613.

Healthcare providers and patients should contact DePuy Orthopaedics for further instructions regarding the removal of these specific components from inventory or use.

The recalled product

Product
ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Implant
Hazard

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 (17)

  • Lot#: 9558300
  • Product Code: 150670003
  • GTIN 10603295492054 Lot#: 9555958
  • Product Code: 150670004
  • GTIN 10603295492061 Lot#: 9554006
  • Product Code: 150670005
  • GTIN 10603295492078 Lot#: 9556397
  • GTIN 10603295492078 Lot#: 9558618
  • Product Code: 150670006
  • GTIN 10603295492085 Lot#: 9557992
  • Product Code: 150670007
  • GTIN 10603295492092 Lot#: 9558238
  • Product Code: 150670008
  • GTIN 10603295492108 Lot#: 9558239
  • GTIN 10603295492108 Lot#: 9555613
  • Product Code: 150670009
  • GTIN 10603295492115

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 3 recalled by DePuy Orthopaedics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · DePuy Orthopaedics, Inc.

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Same hazard · damaged packaging

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