Z-2603-2023Class II

DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106

Name: Z-2603-2023 DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Creator: Encore Medical, LP
Published: 2023-08-04
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2023-08-04 / Open, Classified / root cause: manufacturing process

FDA source

Encore Medical, LP began a recall of DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 on 2023-08-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2603-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-04
Posted: 2023-09-19
Recalling firm: Encore Medical, LP
Product: DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 8/4/23, recall notices were mailed to surgeons and distributors. They were reminded that starting on 7/3/23 they were contacted by the firm, and asked to quarantine affected devices, and that the affected devices had since been retrieved by the firm's sales representatives. Surgeons were asked to take the following actions: 1) We ask that you reach out to your patient[s] who were implanted with affected components as identified above and consider whether it may be appropriate for your patient to be monitored more closely to watch for signs and symptoms of acute or chronic infection. 2) We have also provided a patient letter for you to provide to your patient[s] who was [were] implanted with an affected component[s] should you prefer a written notification to accompany your verbal contact. 3) Please make the hospital where you implanted the components aware of this action, as appropriate by providing a copy of this communication or verbally notifying the hospital. 4) Please review and complete the enclosed Voluntary Recall Response Form. If you have any questions phone the firm at 1(800)456-8696 between the hours of 7:30AM-6:00PM CST, or e-mail [email protected] In addition, distributors were asked to do the following: Provide the notification to any additional organizations or members within your facility or network where devices subject to this voluntary recall may have been transferred.
Quantity in commerce: 20
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
Product codes and lots: UDI-DI/Lot/Expiration: 00190446258032/308V1112/May 25, 2029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2603-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2603-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-19
Z-2604-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-19
Z-2605-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-19
Z-2606-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-19
Z-2607-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-19

Product code JWH

K173723Class IIEMPOWR Universal Tibial BaseplateEncore Medical L.P. / cleared 2018-03-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)