Z-0258-2024Class II

DJO EMPOWR Knee Punch Handle, REF: 801-05-040

Name: Z-0258-2024 DJO EMPOWR Knee Punch Handle, REF: 801-05-040
Creator: Encore Medical, LP
Published: 2023-09-29
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2023-09-29 / Open, Classified

FDA source

Encore Medical, LP began a recall of DJO EMPOWR Knee Punch Handle, REF: 801-05-040 on 2023-09-29. FDA classified it as Class II and gives the reason as "Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0258-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-29
Posted: 2023-11-07
Recalling firm: Encore Medical, LP
Product: DJO EMPOWR Knee Punch Handle, REF: 801-05-040
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.
FDA root cause: Process change control
Action: On 9/29/23, recall notices were emailed to customers who were asked to do the following: 1) Knee punch handles should be visually inspected prior to use for any damage. Upon completion of surgery, visually inspect and verify there is no breakage. The attached quality bulletin provides guidance on an acceptable and unacceptable device. 2) Contact your customer service rep at [email protected] to report failures or to request replacements. 3) Complete and return the response form that asks customers to check all related devices in inventory and report the number of related devices in inventory. Questions can be directed to [email protected]
Quantity in commerce: 406
Distribution: US: VA, TN, MN, TX, IL, IN, KY, OH, SC, MS, RI, ME, NJ, NY, MD, CA, KS, LA, PR, AL, FL, GA, AZ, WA
Product codes and lots: UDI-DI: 00190446238881, Lots: 305197L02D, 305197L02E, 318871L10D, 318871L10E, 305197L02B, 305197L02C, 318871L10B, 318871L10C, 325045L17A, 325045L17B, 325045L17C, 305197L02, 318871L10, 325045L17, 327669L03, 331146L01, 332158L06, 334314L04, 336735L04, 336801L01, 340391L01, 341961L01, 342586L01, 346101L01, 350076L01, 351106L02, 360277L01, 366833L03, 374648L01, 380510L01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0258-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0258-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-07

Product code MBH

K171991Class IIEMPOWR Porous Knee SystemEncore Medical L.P. / cleared 2017-10-04

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)