Recall Z-0060-2021 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Encore Medical, LP
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.
| Date | Oct 7, 2020 (initiated Aug 3, 2020) |
| Status | Open, Classified |
| 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. |
| Root cause | Process change control |
| Action | On August 3, 2020, Field Safety Notices were sent to the firm's distributors by email advising them of this field action, informing them that the firm has received two product complaints where an issue has been experienced with the retaining pin becoming loose and falling out while impacting. Distributors were informed that no adverse events have been reported but that there is a potential of leaving debris in the joint space if this issue were to occur and remain undetected. The letter requests distributors to communicate the following information to implanting surgeons to avoid the potential |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171991 | EMPOWR Porous Knee System Encore Medical L.P., Oct 4, 2017 |