FDA Device recall Z-1257-2022
DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
- FDA Device
- Class II
- ongoing
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class II recall of DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708 by Encore Medical, citing A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1257-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-05 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Encore Medical |
| Distribution | US |
Product
DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
Reason
A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
Identifiers
| code_info | Lot number 078T1141 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1257-2022%22
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