Z-2104-2021Class II

DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2...

Name: Z-2104-2021 DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2...
Creator: Encore Medical, LP
Published: 2021-05-12
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2021-05-12 / Open, Classified / root cause: packaging

FDA source

Encore Medical, LP began a recall of DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185 on 2021-05-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2104-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-12
Posted: 2021-07-20
Recalling firm: Encore Medical, LP
Product: DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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.
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: On 5/12/2021, Encore Medical, LP (DJO) issued a "Urgent Field Safety Notice" via E-Mail. In addition to informing consignees about the recalled product the firm asked consignees to take the following actions by May 26, 2021: 1. This notice needs to be passed on to all those within your organization or to any outside organization or customer where the potentially affected product has been transferred. This recall should be carried out to the user level. 2.Review your stock for the affected products and lot numbers and quarantine the items until returned. 3. Contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. You will be provided with a shipping label to return the affected product. 4. Return all affected devices (quantities listed above) using the RMA number. 5. Complete Field Safety Notice Consignee Reconciliation Form (Attachment 1) and return to DJO by May 26, 2021 (see return instructions in Attachment 1) 6. Report any adverse events related to this issue to Customer Service. Your actions above will demonstrate that you have received and understand this notification. Your assistance is appreciated and necessary to prevent the potential health hazards noted above. 7. If you have any questions, please contact Kiersten Soderman at 864-322-3801 or [email protected].
Quantity in commerce: 10 units
Distribution: US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None
Product codes and lots: Lot # 155T1035

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2104-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2103-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-20
Z-2104-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-20

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)