Z-1524-2021Class II

DJO EMPOWR KNEE Femoral Sizer

Name: Z-1524-2021 DJO EMPOWR KNEE Femoral Sizer
Creator: Encore Medical, LP
Published: 2021-02-05
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2021-02-05 / Open, Classified / root cause: manufacturing process

FDA source

Encore Medical, LP began a recall of DJO EMPOWR KNEE Femoral Sizer on 2021-02-05. FDA classified it as Class II and gives the reason as "Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction". 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-1524-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-02-05
Posted: 2021-04-30
Recalling firm: Encore Medical, LP
Product: DJO EMPOWR KNEE Femoral Sizer
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 02/05/2021, the firm sent an "URGENT FIELD SAFETY NOTICE" Recall letter to customers via e-mail informing them that a product complaint was received where a subcomponent of the sizer was assembled incorrectly. As a result, the windows provided to show the size are facing the opposite direction. When the sizer is in place, the size read from the distal facing side of the instrument is obscured. The risks associated with this issue include: -Delay in surgery -Revision surgery Customers are instructed to the below actions by February 26, 2021: 1. This notice needs to be passed on to all those within their organization or to any organization where the potentially affected product has been transferred. 2. Review their stock for the affected products and lot numbers and to quarantine the items until returned. 3. Contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. Customers will be provided with a shipping label to return the affected product. 4. Return all affected devices (quantities listed above) using the RMA number. Any questions or assistance - contact the Manager, Regulatory Affairs at e-mail [email protected]
Quantity in commerce: 16 units
Distribution: U.S.: FL, IN, and MN O.U.S.: None
Product codes and lots: Model Number: 800-05-034 Lot Number: 326336L02

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1524-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1524-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-12	2021-04-30

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)