DJO SURGICAL 801-05-364Recalls & reported problems
Encore Medical, L.P. · DJO EMPOWR KNEETM Tibial Template, 9 Left · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190446239062), received between Jun 8, 2024 and Nov 10, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
3 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
Most reported problems
Device problems
- Mechanical Problem1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2025Mechanical Problem; Mechanical Problem
COMPLAINT - A FEW PIECES OF METAL DETACHED FROM THE TIBIAL PLATE. 30 MINUTE DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23519103 ↗InjuryJun 8, 2024No Apparent Adverse Event; No Apparent Adverse Event
INSTRUMENT FAILURE - TIBIA TRAY BROKE WHEN USING PUNCHING YOUR TIBIA WITH PUNCH, LEFT KNEE, 30 MINUTE DELAY IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19495039 ↗
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-0258-2024 · Sep 29, 2023 · Open, ClassifiedDJO EMPOWR Knee Punch Handle, REF: 801-05-040
- 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 Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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
- 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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