Z-1384-2023Class II

EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108

Name: Z-1384-2023 EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Creator: Encore Medical, LP
Published: 2023-02-28
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2023-02-28 / Open, Classified

FDA source

Encore Medical, LP began a recall of EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108 on 2023-02-28. FDA classified it as Class II and gives the reason as "Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1384-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-28
Posted: 2023-04-12
Recalling firm: Encore Medical, LP
Product: EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during surgery, there is risk of the implant loosening, implant not properly fitting, and/or fractured bone.
FDA root cause: Process change control
Action: On 2/28/23, field safety notices were emailed to surgical sales agents who were asked to document the quantity of affected devices complete and return the acknowledgement form. Customer service contact, [email protected], was provided to report failures or to request replacements. Customers with questions can phone (914) 450-3931, or email [email protected].
Quantity in commerce: 29
Distribution: US: TX, IN, MD, CA, KS, AL, HI, WA
Product codes and lots: REF/UDI-DI/Lot: 802-05-104/00190446238843/388620L01; 802-05-108/00190446365907/388620L03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1384-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1384-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-19	2023-04-12

Product code MBH

K212941Class IIPorous PatellaEncore Medical, L.P. Dba Djo Surgical / cleared 2022-01-20

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)