DJO SURGICAL 803-15-001Recalls & reported problems
Encore Medical, L.P. · Straight Acet. Impactor, Empowr · Class 1
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 00190446289210), received between Aug 9, 2022 and Aug 9, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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
- Difficult to Insert1
- Difficult to Remove1
- Physical Resistance/Sticking1
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.
MalfunctionAug 9, 2022Difficult to Insert; Difficult to Remove; Physical Resistance/Sticking
INSTRUMENT FAILURE - THE SURGEON ATTEMPTED TO IMPACT THE CUP INTO THE PATIENT. THE CUP WOULD NOT DISLODGE/UNSCREW FROM THE IMPACTOR. AFTER SEVERAL FAILED ATTEMPTS TO UNSCREW IT THE SURGEON REMOVED THE CUP AND IMPACTOR AND PUT IN A NEW CUP USING A NEW IMPACTOR. AFTER IMPACTION OF THE SECOND CUP THE SECOND IMPACTOR WOULD NOT UNSCREW FROM THE SECOND CUP INITIALLY. AFTER SEVERAL ATTEMPTS THE SURGEON REMOVED THE SECOND CUP AND IMPACTOR FROM THE PATIENT. ONCE OUT OF THE PATIENT, THE SURGEON WAS ABLE TO REMOVE THAT CUP, AFTER SEVERAL MORE ATTEMPTS BY USING A SCREWDRIVER TO LEVERAGE THE IMPACTOR. HE THEN WANTED TO USE A THIRD IMPACTOR TO IMPLANT THE SECOND CUP AND DID SO SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 15194712 ↗
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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