Recall Z-0126-2023— Encore Medical, LP
Class II · Ongoing
Class II FDA medical device recall by Encore Medical, LP, initiated 2022-08-12. It names one FDA 510(k) clearance: K143242. Product: EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.. 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..
- Recalling firm
- Encore Medical, LP
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-08-12
- Firm location
- Austin, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.