Z-1257-2022Class II

DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708

Name: Z-1257-2022 DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
Creator: Encore Medical, LP
Published: 2022-05-05
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2022-05-05 / Open, Classified / root cause: labeling and UDI

FDA source

Encore Medical, LP began a recall of DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708 on 2022-05-05. FDA classified it as Class II and gives the reason as "A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1257-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-05
Posted: 2022-06-09
Recalling firm: Encore Medical, LP
Product: DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On 05/05/2022, recall notices were emailed to DJO Surgical Agents by Enovis. Notices state that DJO Surgical requires the following actions: 1) Pass on the recall notice within your organization or to any organization where the potentially affected product has been transferred. 2) Contact Customer Service at 1-800-456-8696 to place a replacement order and to receive an RMA number to return affected devices. 3) Customers with questions or issues can contact Customer Service.
Quantity in commerce: 20
Distribution: U.S. Nationwide distribution in the states of TN, MN, IL, IN, SC, MS, CA, KS.
Product codes and lots: Lot number 078T1141

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1257-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1257-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-09

Product code JWH

K143242Class IIRebel 3DKNEE SystemEncore Medical L.P. / cleared 2015-05-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)