Encore Medical, Lp: Medical Device Recall in 2019 - (Recall #: Z-0611-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096

Product Classification:

Class II

Date Initiated: February 4, 2019

Date Posted: December 18, 2019

Recall Number: Z-0611-2020

Event ID: 84151

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

Status: Ongoing

Product Quantity: 410 devices

Code Information:

All Lots

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated