Recall Z-2604-2023— Encore Medical, LP

Name: FDA recall Z-2604-2023
Creator: U.S. Food and Drug Administration
Published: 2023-08-04

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2023-08-04. It names one FDA 510(k) clearance: K082844. Product: DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443. 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.

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2023-08-04
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K082844 — BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVEEncore Medical L.P.·cleared 2008-11-25

K-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

DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.