Recall Z-2103-2021— Encore Medical, LP

Name: FDA recall Z-2103-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-12

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2021-05-12. It names one FDA 510(k) clearance: K143242. Product: DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980. Reason: Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2021-05-12
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K143242 — Rebel 3DKNEE SystemEncore Medical L.P.·cleared 2015-05-15

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 EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980

Reason for recall

Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.

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