DJO SURGICAL 341-12-711Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 11L 12MM, VE · 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
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888912166980), received between Feb 9, 2018 and Aug 18, 2026 — classified as 11 injuries.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
- Jun 2, 2025Class IIOpen, Classified
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
Z-2126-2025 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Appropriate Device Problem Term/Code Not Available3
- Device Markings/Labelling Problem1
- Inadequacy of Device Shape and/or Size1
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
- Unstable1
Patient problems
- Unspecified Infection5
- Insufficient Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Joint Laxity1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2026No Apparent Adverse Event
Revision surgery - Due to Unknown revision reason / Poly Swap.
Patient problems: Insufficient Information
MAUDE report 50291510 ↗InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO POLY SWAP , REASON UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 22102177 ↗InjuryAug 23, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 28, 2022Appropriate Device Problem Term/Code Not Available
InjuryMar 23, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - IRRIGATION AND DRAINAGE LINER EXCHANGE PERFORMED DUE TO INFECTION FROM A SPIDER BITE.
Patient problems: Unspecified Infection
MAUDE report 13865556 ↗InjuryMay 14, 2021Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem
PRIMARY SURGERY - WRONG INSERT PACKAGED IN WRONG BOX. (16MM INSERT) A LEFT, SIZE 11, 12MM EMPOWR 3D KNEE INSERT PACKAGE WAS OPENED AND A LEFT, SIZE 11, 16MM EMPOWR 3D KNEE INSERT WAS INSIDE. THE SURGEON CONTINUED WITH THE TRIALING PROCESS AND ENDED UP IMPLANTING A SIZE 11, 14MM EMPOWR 3D KNEE INSERT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11829531 ↗InjuryJun 28, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO POLY SWAP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8745274 ↗InjuryFeb 9, 2018Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT SHOWING SIGNS OF INFECTION. THE SURGEON DID AN IRRIGATION AND DRAINAGE (I&D) AND A POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 7260148 ↗
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 · 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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