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.
This recall has been terminated (originally issued February 22, 2021).
- Company
- Depuy Orthopaedics, Inc.
- Recall Initiated
- February 22, 2021
- Terminated
- October 11, 2023
- Recall Number
- Z-1316-2021
- Quantity
- 355 units total (Domestic: 177 units, Foreign: 178 units)
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
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.
Distribution
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.
Lot / Code Info
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
Root Cause
Packaging change control
Action Taken
On 02/25/2021, Depuy Synthes issued an Urgent Medical Device Recall notices to customers via email. DePuy (Ireland) UC is initiating a voluntary removal for the 12 lots for 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.