EMPOWR Partial Knee Peg Drill Guide — Class II medical device recall Z-0479-2021
Ongoing recall by Encore Medical, LP, reported 2020-12-02, distributed in AZ, CA, FL, GA, IL, IN, MI, MN…. There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral poster
| Recall number | Z-0479-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2020-06-19 |
| Classified | 2020-11-20 |
| Reported by FDA | 2020-12-02 |
| Distributed | AZ, CA, FL, GA, IL, IN, MI, MN, NY, TX, VA, WA |
| Quantity | 28 units |
| Model numbers | 800-06-007 |
Product
EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.
Reason for recall
There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.
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-0479-2021. 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.