Recall Z-1316-2021 ยท NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
DePuy Orthopaedics, Inc.
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.
| Date | Feb 22, 2021 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging change control |
| Action | 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. |
| Quantity | 355 units total (Domestic: 177 units, Foreign: 178 units) |
| 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, Franc |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.