Z-0060-2021Class II

DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for...

Name: Z-0060-2021 DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for...
Creator: Encore Medical, LP
Published: 2020-08-03
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2020-08-03 / Open, Classified

FDA source

Encore Medical, LP began a recall of DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch... on 2020-08-03. FDA classified it as Class II and gives the reason as "There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0060-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-08-03
Posted: 2020-10-07
Recalling firm: Encore Medical, LP
Product: DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of three appropriately sized Tibial Punch Guides to broach the tibial canal in preparation for the tibial baseplate keel.
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space.
FDA root cause: Process change control
Action: On August 3, 2020, Field Safety Notices were sent to the firm's distributors by email advising them of this field action, informing them that the firm has received two product complaints where an issue has been experienced with the retaining pin becoming loose and falling out while impacting. Distributors were informed that no adverse events have been reported but that there is a potential of leaving debris in the joint space if this issue were to occur and remain undetected. The letter requests distributors to communicate the following information to implanting surgeons to avoid the potential of leaving debris in the joint space: 1. Sales representative is to inspect instrumentation before every surgery per the Instructions For Use. A small object should be pushed against the end of the pin to confirm it is securely fixed in place. 2. The sales rep should warn of the possibility of the loose pin and steps to take to confirm containment of the loose pin in order to mitigate patient risk. 3. After use of the instrument, it should be verified that the pin remains fixed in place. Distributors were informed that when devices that meet specification become available for the 5 impacted lots, a field exchange will occur as part of a reportable recall. Distributors are requested to complete the acknowledgment form and return it by 8-10-2020 to confirm that they have read and understood best practices for use of the knee punch handle, and have disseminated the information to all employees and contracted Sales Representatives. Customers with questions should contact Teffany Hutto by phone at (512) 834-6255 or by email at [email protected]. On 03/12/2021, recall notices were emailed to additional customers informing them of additional affected models/lots.
Quantity in commerce: 190 units
Distribution: U.S. Nationwide distribution including in the states of VA, TN, MN, TX, IL, IN, KY, OH, SC, RI, MD, PA, NY, CA, KS, OK, AR, LA, FL, AL, GA, AZ, NV, WA, MS, ME, NV and Puerto Rico.
Product codes and lots: Model/Catalog no. 801-05-040; :Lot/serial No.s 281905L08, 281905L15, 283808L01, 305197L02, 318871L10 Model/Catalog no. 801-05-018, Lot/serial No.s: 215488L08, 236760L01, 228231L01, 241946L02, 259710L01, 314969L01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0060-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0060-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-10-14	2020-10-07

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