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.
Recall
- Recall Number
- Z-1316-2021
- Event Number
- 87433
- Firm
- DePuy Orthopaedics, Inc.
- FEI Number
- 1818910
- Product Code
- NJL
- Status
- Terminated
- Root Cause
- Packaging change control
- Initiated
- February 22, 2021
- Terminated
- October 11, 2023
- Address
- 700 Orthopaedic Dr, Warsaw, IN, 46582-3994
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.
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.
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.
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.
355 units total (Domestic: 177 units, Foreign: 178 units)