Z-0060-2021 Class II Ongoing
FDA device recall Z-0060-2021 was initiated by Encore Medical, LP on Aug 3, 2020 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 190 units.
Recall details
- Product Type
- Devices
- Report Date
- Oct 14, 2020
- Initiation Date
- Aug 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 190 units
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.
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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0060-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026