FDA Device recall Z-0479-2021
EMPOWR Partial Knee Peg Drill Guide
- 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 Guide 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-0479-2021 |
| 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 Guide; Model: 800-06-007.
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.
Other recalls by Encore Medical
- Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee…
FDA Device · Class II · 2026-07-15 · Encore Medical - Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee…
FDA Device · Class II · 2026-07-15 · Encore Medical - Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 5…
FDA Device · Class II · 2026-03-04 · Encore Medical - Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00…
FDA Device · Class II · 2026-03-04 · Encore Medical - Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
FDA Device · Class II · 2026-03-04 · Encore Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0479-2021%22
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