DJO SURGICAL 342-16-705Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 5R 16MM, 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
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912167628), received between May 21, 2018 and Dec 9, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Packaging 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
- Dec 18, 2024Class IIOpen, Classified
5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
Z-0766-2025 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Appropriate Device Problem Term/Code Not Available2
- Packaging Problem1
Patient problems
- Unspecified Infection3
- Discomfort1
- Loss of Range of Motion1
- No Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryDec 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FULL REMOVAL DUE TO INFECTION. ITEMS WERE REPLACED WITH SPACERS.
Patient problems: Unspecified Infection
MAUDE report 23763826 ↗InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO POOR RANGE OF MOTION.
Patient problems: Loss of Range of Motion
MAUDE report 18000401 ↗InjuryApr 19, 2022Appropriate Device Problem Term/Code Not Available
InjurySep 25, 2019Appropriate Device Problem Term/Code Not Available
InjuryMay 21, 2018Packaging Problem
COMPLAINT - DUE TO THE PACKAGING FOR THE 3D INSERT NOT BEING IN THE NORMAL PACKAGING THAT THE INSERTS COME IN. INSTEAD THE PACKAGING IS IDENTICAL TO THE POSTERIOR STABILIZED (PS) INSERT. THE PACKAGE HAS NOT BEEN OPENED, SENDING BACK FOR REVIEW.
Patient problems: No Information
MAUDE report 7531182 ↗
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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