FDA Device recall Z-0480-2021
EMPOWR Partial Knee Peg Drill
- FDA Device
- Class II
- ongoing
- Published 2020-12-02
On 2020-12-02 the FDA classified a Class II recall of EMPOWR Partial Knee Peg Drill by Encore Medical, citing 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 withi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0480-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-06-19 |
| Published | 2020-12-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Encore Medical |
| Distribution | AZ, CA, FL, GA, IL, IN, MI, MN, NY, TX, VA, WA |
Product
EMPOWR Partial Knee Peg Drill; Model: 800-06-008.
Reason
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.
Identifiers
| code_info | all lot numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0480-2021%22
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