DJO SURGICAL 803-15-002Recalls & reported problems
Encore Medical, L.P. · OFFSET ACET. IMPACTOR, EMPOWR · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00190446286479), received between Nov 1, 2021 and Nov 7, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
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
- Break3
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2021Break
INSTRUMENT FAILURE - ITEM BROKE DURING SURGERY. A TOTAL OF THREE BROKEN WITHIN A WEEK TIME FRAME BETWEEN THREE DIFFERENT CASES.
Patient problems: Insufficient Information
MAUDE report 12759066 ↗MalfunctionNov 7, 2021Break
INSTRUMENT FAILURE - ITEM BROKE DURING SURGERY. A TOTAL OF THREE BROKEN WITHIN A WEEK TIME FRAME BETWEEN THREE DIFFERENT CASES.
Patient problems: Insufficient Information
MAUDE report 12759034 ↗MalfunctionNov 1, 2021Break
INSTRUMENT FAILURE - ITEM BROKE DURING SURGERY. A TOTAL OF THREE BROKEN WITHIN A WEEK TIME FRAME BETWEEN THREE DIFFERENT CASES.
Patient problems: Insufficient Information
MAUDE report 12733921 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 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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