Encore Medical, LP Recall: DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF:
Encore Medical, LP Recall: DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Encore Medical, LP; Product: DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106; Reason for recall: Orthopedic device compone
| Recalling firm | Encore Medical, LP |
|---|---|
| Product | DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 |
| Reason for recall | 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 |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| 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 |
| Recall initiated | 20230804 |
| Recall number | Z-2603-2023 |
| Category | device |
| State | TX |
| Country | United States |
$29/mo
Try RecallGuard →