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.
Reported: October 14, 2020 Initiated: August 3, 2020 #Z-0060-2021
Product Description
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.
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.
Details
- Recalling Firm
- Encore Medical, LP
- Units Affected
- 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.
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Encore Medical, LP. Units affected: 190 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 14, 2020. Severity: Moderate. Recall number: Z-0060-2021.
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