DePuy Orthopaedics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1316-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 22, 2021

Date Posted: April 7, 2021

Recall Number: Z-1316-2021

Event ID: 87433

Reason for Recall:

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.

Status: Terminated

Product Quantity: 355 units total (Domestic: 177 units, Foreign: 178 units)

Code Information:

Lot: 9557372, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557439, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557440, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557450, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557460, Product Code: 150680003, GTIN: 10603295492153 Lot: 9557444, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557445, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557446, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557453, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557455, Product Code: 150680004, GTIN: 10603295492160 Lot: 9557376, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557377, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557457, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557471, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557473, Product Code: 150680005, GTIN: 10603295492177 Lot: 9557476, Product Code: 150680005, GTIN: 10603295492177 Lot: 9556100. Product Code: 150680006, GTIN: 10603295492184 Lot: 9556127, Product Code: 150680006, GTIN: 10603295492184 Lot: 9556128, Product Code: 150680006, GTIN: 10603295492184 Lot: 9557434, Product Code: 150680007, GTIN: 10603295492191

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Brazil, Austria, Belgium, Denmark, Estonia, France, Germany, Great Britain, Ireland, Israel, Italy, Macedonia, Mauritius, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, South Africa, Sweden, Switzerland, United Arab Emirates, China, Hong Kong, Japan, New Zealand, Korea, Singapore, Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated