Reported Apr 7, 2021 · Terminated
The ATTUNE¿ Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to…
DePuy Orthopaedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- The ATTUNE¿ Rotating Platform (RP)
- Total Knee System - Product Usageconsists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint
- Lot codes and dates
20 of 20 products
Products covered by this recall Model / number Product as published 10603295492153Lot: 9557372, Product Code: 150680003 10603295492153Lot: 9557439, Product Code: 150680003 10603295492153Lot: 9557440, Product Code: 150680003 10603295492153Lot: 9557450, Product Code: 150680003 10603295492153Lot: 9557460, Product Code: 150680003 10603295492160Lot: 9557444, Product Code: 150680004 10603295492160Lot: 9557445, Product Code: 150680004 10603295492160Lot: 9557446, Product Code: 150680004 10603295492160Lot: 9557453, Product Code: 150680004 10603295492160Lot: 9557455, Product Code: 150680004 10603295492177Lot: 9557376, Product Code: 150680005 10603295492177Lot: 9557377, Product Code: 150680005 10603295492177Lot: 9557457, Product Code: 150680005 10603295492177Lot: 9557471, Product Code: 150680005 10603295492177Lot: 9557473, Product Code: 150680005 10603295492177Lot: 9557476, Product Code: 150680005 10603295492184Lot: 9556100. Product Code: 150680006 10603295492184Lot: 9556127, Product Code: 150680006 10603295492184Lot: 9556128, Product Code: 150680006 10603295492191Lot: 9557434, Product Code: 150680007 - Amount recalled
- 355 units total (Domestic: 177 units, Foreign: 178 units)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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