Z-0480-2021Class II

EMPOWR Partial Knee Peg Drill; Model: 800-06-008

Name: Z-0480-2021 EMPOWR Partial Knee Peg Drill; Model: 800-06-008
Creator: Encore Medical, LP
Published: 2020-06-19
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2020-06-19 / Open, Classified

FDA source

Encore Medical, LP began a recall of EMPOWR Partial Knee Peg Drill; Model: 800-06-008 on 2020-06-19. FDA classified it as Class II and gives the reason as "There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0480-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-06-19
Posted: 2020-11-20
Recalling firm: Encore Medical, LP
Product: EMPOWR Partial Knee Peg Drill; Model: 800-06-008.
Product code: HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Reason for recall: There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.
FDA root cause: Other
Action: The method of notification was via e-mail to surgical sales agents, and the notices were issued on 06/18/2020. Additionally, a notification to return the affected drills for replacement were sent via e-mail to affected surgical agents on 07/20/20. The following recommendations should be communicated to the implanting surgeons: Sales Agents Action: To avoid the potential binding, the following is recommended: " Use a plunge mill approach, i.e. plunge the drill in and out of the drill guide bushing a few times slowly until the hole is fully prepared. " Use of saline or fat to keep the drill lubricated during use. " Inspect all instrumentation prior to use to identify any wear, breakage or damage. Along with the notification, the communication includes an acknowledgment form that should be completed and returned to confirm that the instructions provided have been read and understood. THE ACKNOWLEDGEMENT SHOULD BE REVIEWED AND COMPLETED BY JULY 6, 2020.For questions, contact Teffany Hutto by phone at (512) 834-6255 or by email at [email protected].
Quantity in commerce: 28 units
Distribution: US: AZ, CA, FL, GA, IL, IN, MI, MN, NY, TX, VA, and WA.. No OUS Consignees.
Product codes and lots: all lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0480-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0479-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-02	2020-11-20
Z-0480-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-02	2020-11-20

Product code HSX

K191325Class IIEMPOWR Partial KneeEncore Medical L.P. / cleared 2019-07-16

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)