DJO SURGICAL 804-02-035Recalls & reported problems
Djo, LLC · RSP, HEAD DISTRACTOR · Class 1
All models of DJO SURGICAL (42)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912147217), received between Oct 1, 2021 and Oct 1, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).
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.
Most reported problems
Device problems
- Material Twisted/Bent1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 1, 2021Material Twisted/Bent
INSTRUMENT FAILURE: THE INCIDENT OCCURED WHILE REMOVING A GLENOSPHERE TRIAL FROM THE PATIENT DURING SURGERY. THE PATIENT WAS TIGHT AND THERE WAS NOT MUCH SPACE TO INSERT/REMOVE THE TRIAL AND INSTRUMENT. TIP OF TRIAL REMOVAL T-HANDLE BENT DURING THIS REMOVAL.
Patient problems: Insufficient Information
MAUDE report 12561821 ↗
Other EXTRACTOR devices
- ATTUNE 2545-00-138Depuy (Ireland) · EXTRACTOR392 reports
- PINNACLE 2217-50-001Depuy (Ireland) · EXTRACTOR243 reports
- RECLAIM 2975-00-635Depuy (Ireland) · EXTRACTOR157 reports
- ATTUNE 2545-00-060Depuy (Ireland) · EXTRACTOR153 reports
- ESC PINNACLE 2218-00-010Depuy (Ireland) · EXTRACTOR151 reports
- NA 2125-00-600Depuy Orthopaedics, Inc. · EXTRACTOR130 reports
- P.F.C. 86-5226Depuy (Ireland) · EXTRACTOR80 reports
- NA 03.010.000Synthes GmbH · EXTRACTOR74 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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