FDA Device recall Z-0258-2024
DJO EMPOWR Knee Punch Handle, REF: 801-05-040
- FDA Device
- Class II
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class II recall of DJO EMPOWR Knee Punch Handle, REF: 801-05-040 by Encore Medical, citing knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0258-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-29 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Encore Medical |
| Distribution | AL, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MD, ME, MN, MS, NJ, NY, OH, PR, RI, SC, TN, TX, VA, WA |
Product
DJO EMPOWR Knee Punch Handle, REF: 801-05-040
Reason
Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.
Identifiers
| code_info | UDI-DI: 00190446238881, Lots: 305197L02D, 305197L02E, 318871L10D, 318871L10E, 305197L02B, 305197L02C, 318871L10B, 31887…UDI-DI: 00190446238881, Lots: 305197L02D, 305197L02E, 318871L10D, 318871L10E, 305197L02B, 305197L02C, 318871L10B, 318871L10C, 325045L17A, 325045L17B, 325045L17C, 305197L02, 318871L10, 325045L17, 327669L03, 331146L01, 332158L06, 334314L04, 336735L04, 336801L01, 340391L01, 341961L01, 342586L01, 346101L01, 350076L01, 351106L02, 360277L01, 366833L03, 374648L01, 380510L01 |
|---|
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-0258-2024%22
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