DJO EMPOWR Tibial Knee Punch Handle Part No — Class II medical device recall Z-0060-2021
Ongoing recall by Encore Medical, LP, reported 2020-10-14, distributed nationwide. There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impac
| Recall number | Z-0060-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2020-08-03 |
| Classified | 2020-10-07 |
| Reported by FDA | 2020-10-14 |
| Distributed | Nationwide (US) |
| Quantity | 190 units |
| Serial numbers | 215488L08, 228231L01, 236760L01, 241946L02, 259710L01, 281905L08, 281905L15, 283808L01, 305197L02, 314969L01, 318871L10 |
| Model numbers | 801-05-018, 801-05-040 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0060-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.