Recall Z-0126-2023 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Encore Medical, LP
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
| Date | Oct 21, 2022 (initiated Aug 12, 2022) |
| Status | Open, Classified |
| Reason | Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery. |
| Root cause | Process control |
| Action | On 8/12/22, recall notices were emailed to DJO Surgical Agents who were informed to do the following: 1) Pass the notice to all those within your organization or to any organization where the potentially affected devices have been transferred. 2) Return affected devices 3) Complete and return the response form Questions, contact: Julie.Baker@Enovis.com |
| Quantity | 18 |
| Distribution | US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143242 | Rebel 3DKNEE System Encore Medical L.P., May 15, 2015 |