Data Foundry

Medical device recalls 2023

DJO EMPOWR Knee Punch Handle — Class II medical device recall Z-0258-2024

Ongoing recall by Encore Medical, LP, reported 2023-11-15, distributed in AL, AZ, CA, FL, GA, IL, IN, KS…. Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disrup

Recall numberZ-0258-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmEncore Medical, LP, Austin, TX, United States
Recall initiated2023-09-29
Classified2023-11-07
Reported by FDA2023-11-15
DistributedAL, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MD, ME, MN, MS, NJ, NY, OH, PR, RI, SC, TN, TX, VA, WA
Quantity406
UPC / GTIN / UDI-DI00190446238881
Lot numbers305197L02, 305197L02B, 305197L02C, 305197L02D, 305197L02E, 318871L10, 318871L10B, 318871L10C, 318871L10D, 318871L10E, 325045L17, 325045L17A, 325045L17B, 325045L17C, 327669L03, 331146L01, 332158L06, 334314L04, 336735L04, 336801L01, 340391L01, 341961L01, 342586L01, 346101L01, 350076L01, 351106L02, 360277L01, 366833L03, 374648L01, 380510L01
Model numbers801-05-040

Product

DJO EMPOWR Knee Punch Handle, REF: 801-05-040

Reason for recall

Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.

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-0258-2024. 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.