DJO SURGICAL 801-05-040Recalls & reported problems
Encore Medical, L.P. · DJO EMPOWR KNEETM Punch Handle · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00190446238881), received between Jul 23, 2021 and Apr 11, 2024 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Break” (6 reports).
1 FDA recall record name this device's identifier, 1 still open.
2 other recalls cover devices cleared under the same FDA submission (K171991); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Sep 29, 2023Class IIOpen, Classified
Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.
Z-0258-2024 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break6
- No Apparent Adverse Event1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryApr 11, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THERE WAS A 40 MINUTE DELAY IN SURGERY.
Patient problems: Insufficient Information
MAUDE report 19093730 ↗MalfunctionFeb 14, 2022Break
INSTRUMENT FAILURE - END OF TIBIAL PUNCH HANDLE BROKE ON IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13522881 ↗MalfunctionJan 4, 2022Break
INSTRUMENT FAILURE, THE PART BROKE.
Patient problems: Insufficient Information
MAUDE report 13161100 ↗MalfunctionDec 20, 2021Break
INSTRUMENTAL FAILURE THE TIBIAL PUNCH INSERTER BROKE OFF INSIDE THE PATIENT. ALL PIECES WERE RETRIEVED. SMALL DELAY IN CASES.
Patient problems: Foreign Body In Patient
MAUDE report 13047029 ↗MalfunctionAug 18, 2021Break
INSTRUMENT FAILURE - IMPACTOR HANDLE BROKE DURING CASE - TIBIA BASE PLATE NOTHING LEFT INSIDE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12338613 ↗MalfunctionAug 18, 2021Break
INSTRUMENT FAILURE - IMPACTOR HANDLE BROKE DURING FEMUR TRIAL PLACEMENT NOTHING WAS LEFT INSIDE PATIENT.
Patient problems: Insufficient Information
MAUDE report 12338598 ↗MalfunctionJul 23, 2021Break
INSTRUMENT FAILURE - SURGEON WAS MALLETING INSTRUMENT CORRECTLY AND THE INSTRUMENT BROKE.
Patient problems: Insufficient Information
MAUDE report 12218163 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K171991. One submission often covers many models, so check the product and lot details in each record.
- Z-0508-2024 · Nov 10, 2023 · Open, ClassifiedDJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108
- Z-0060-2021 · Aug 3, 2020 · Open, ClassifiedDJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conj
Other PUNCH, SURGICAL devices
- SIGMA LCS HIGH PERFORMANCE 9505-02-012Depuy Orthopaedics, Inc. · PUNCH, SURGICAL85 reports
- SIGMA LCS 9505-02-018Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall10 reports
- SIGMA LCS 9505-02-017Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall1 report
- SIGMA LCS 9505-02-016Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-021Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA LCS 9505-02-020Depuy Orthopaedics, Inc. · PUNCH, SURGICAL1 recall0 reports
- SIGMA HIGH PERFORMANCE 9505-02-047Depuy (Ireland) · PUNCH, SURGICAL33 reports
- SIGMA LCS HIGH PERFORMANCE 9505-02-011Depuy Orthopaedics, Inc. · PUNCH, SURGICAL30 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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