Recall Z-2603-2023 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, LP
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
| Date | Sep 19, 2023 (initiated Aug 4, 2023) |
| Status | Open, Classified |
| Reason | Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery |
| Root cause | Nonconforming Material/Component |
| Action | On 8/4/23, recall notices were mailed to surgeons and distributors. They were reminded that starting on 7/3/23 they were contacted by the firm, and asked to quarantine affected devices, and that the affected devices had since been retrieved by the firm's sales representatives. Surgeons were asked to take the following actions: 1) We ask that you reach out to your patient[s] who were implanted with affected components as identified above and consider whether it may be appropriate for your patient to be monitored more closely to watch for signs and symptoms of acute or chronic infection. 2) We |
| Quantity | 20 |
| Distribution | US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France, UK, Colombia, Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173723 | EMPOWR Universal Tibial Baseplate Encore Medical L.P., Mar 5, 2018 |