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Recall Observatory FDA recall evidence

Device 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.

Z-0060-2021

August 03, 2020

Class II

Product summary

Firm
Encore Medical, LP
Event
Event 86257
Status
Ongoing
Classification
Class II
Quantity
190 units
Official record key
device-enforcement:Z-0060-2021

Official wording

Reason: 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.

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.