The Recall Desk
ModerateFDA (Devices)·Z-1316-2021·Announced 2021-04-07

DePuy ATTUNE Rotating Platform Total Knee System Recalled for Damaged Packaging

DePuy Orthopaedics is recalling 355 units of the ATTUNE Rotating Platform Total Knee System due to potential damaged packaging. The affected tibial bases are used in cemented total knee arthroplasty.

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 involves potential damaged packaging, which is a low-risk contamination or packaging issue without reported injuries, fitting the Moderate severity criteria.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling 355 units of the ATTUNE Rotating Platform (RP) Total Knee System. The recall involves specific lots of tibial bases intended for use in cemented total knee arthroplasty. The company is removing these lots due to potential damaged packaging.

The affected components are distributed worldwide, including nationwide distribution in the United States and in numerous countries across Europe, Asia, Africa, and the Americas. The recall covers 37 lots of MBT & ATTUNE (S+) Tibial Bases.

Consumers and healthcare providers should stop using the affected lots and contact DePuy Orthopaedics for further instructions. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.
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 (20)

  • Lot: 9557372
  • Product Code: 150680003
  • GTIN: 10603295492153 Lot: 9557439
  • GTIN: 10603295492153 Lot: 9557440
  • GTIN: 10603295492153 Lot: 9557450
  • GTIN: 10603295492153 Lot: 9557460
  • GTIN: 10603295492153 Lot: 9557444
  • Product Code: 150680004
  • GTIN: 10603295492160 Lot: 9557445
  • GTIN: 10603295492160 Lot: 9557446
  • GTIN: 10603295492160 Lot: 9557453
  • GTIN: 10603295492160 Lot: 9557455
  • GTIN: 10603295492160 Lot: 9557376
  • Product Code: 150680005
  • GTIN: 10603295492177 Lot: 9557377
  • GTIN: 10603295492177 Lot: 9557457
  • GTIN: 10603295492177 Lot: 9557471
  • GTIN: 10603295492177 Lot: 9557473
  • GTIN: 10603295492177 Lot: 9557476
  • GTIN: 10603295492177 Lot: 9556100. Product Code: 150680006

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 · packaging damage

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