DJO SURGICAL 804-06-311Recalls & reported problems
Encore Medical, L.P. · ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD · Class 2
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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190446843825), received between May 21, 2025 and May 21, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
7 other recalls cover devices cleared under the same FDA submission (K233481); they may or may not involve this specific model.
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
- Jul 18, 2025Class IIOpen, Classified
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Z-2546-2025 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 21, 2025Mechanical Problem; Mechanical Problem
COMPLAINT - DURING OUR CASE WITH DR, WE WERE COMPLETING A REVERSE AUGMENTED GLENOID WHEN THE MAIN OFF AXIS REAMER AND ITS COMPONENTS SEEMINGLY BOUND UP ON EACH OTHER WHEN ATTEMPTING TO REAM FOR THE WEDGE BASEPLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22066793 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K233481. One submission often covers many models, so check the product and lot details in each record.
- Z-2548-2025 · Jul 18, 2025 · Open, ClassifiedBrand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile
- Z-2549-2025 · Jul 18, 2025 · Open, ClassifiedBrand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended
- Z-2547-2025 · Jul 18, 2025 · Open, ClassifiedBrand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile
- Z-2010-2025 · May 28, 2025 · Open, ClassifiedBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.
- Z-2009-2025 · May 28, 2025 · Open, ClassifiedBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.
- Z-2011-2025 · May 28, 2025 · Open, ClassifiedBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.
- Z-2008-2025 · May 28, 2025 · Open, ClassifiedBrand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.
Other shoulder prosthesis, reverse configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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.
How reports and recalls are matched · Editorial policy · Report an error on this page