Z-0611-2020Class II

EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part #...

Name: Z-0611-2020 EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part #...
Creator: Encore Medical, Lp
Published: 2019-02-04
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2019-02-04 / Open, Classified / root cause: design

FDA source

Encore Medical, Lp began a recall of EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096 on 2019-02-04. FDA classified it as Class II and gives the reason as "The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0611-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-02-04
Posted: 2019-12-06
Recalling firm: Encore Medical, LP
Product: EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off axis loading which can increase the risk of device failure. This could cause a delay in surgery. If the tip is not seen during surgery, long term risks may include an inflammatory response, infection, and/ or pain
Root cause tag: design
FDA root cause: Device Design
Action: On February 4, 2019, DJO emailed consignees a Urgent Field Safety Notice" concerning the recalled product. This field safety notices provided consignees "best practices" for use of the device. On August 19, 2019, DJO revised their "Urgent Field Safety Notice" to communicate the exchange process for physical product in consignees inventory. The field safety notices asked consignees to take the following actions: 1. Please locate within your inventory part 800-05-035 in FA K EMP COMP PAT TOOL KIT, FA K EMP PAT TOOL KIT, and FA K EMP PAT TOOL KIT WIMPCTR. The quantities shown within each consignee letter is specific to the consignee. 2. Contact Customer Service to initiate a return of the product via RMA and to have the replacement impactors sent to you. 3. If you have any questions, please contact Teffany Hutto by phone at (512) 834-6255 or by email at [email protected].
Quantity in commerce: 410 devices
Distribution: CO, WA, CA, UT, CA, TN, TX, MS, MO, AR, OK, LA, MN, IL, IN, KY, OH, MI, PA, SC, FL, PR, AL, GA, NM, AZ, NV, VA, RI, MD, ME PA, NY OUS: None
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0611-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0611-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-12-18	2019-12-06

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)