DJO SURGICAL 508-80-001Recalls & reported problems
Encore Medical, L.P. · ALTIVATE REV REVISION MOD BASEPLATE AND TAPER KIT, 8.0mm WDG · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00190446822868), received between Dec 9, 2025 and Jul 27, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Unstable” (3 reports).
8 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
Most reported problems
Device problems
- Unstable3
- Detachment of Device or Device Component1
- Fracture1
- Patient Device Interaction Problem1
Patient problems
- Joint Laxity4
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Unstable
InjuryFeb 24, 2026Detachment of Device or Device Component; Patient Device Interaction Problem
REVISION SURGERY - DUE TO GLENOID WALL COLLAPSED, BROKEN FRAGMENTED PIECE LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient; Joint Laxity
MAUDE report 24437604 ↗InjuryDec 11, 2025Fracture; Unstable; Fracture; Unstable
THE PATIENT DEVELOPED INSTABILITY AFTER HER GREATER TUBEROSITY HAD AN EVULSION FRACTURE.
Patient problems: Insufficient Information; Joint Laxity
MAUDE report 23785740 ↗InjuryDec 9, 2025Unstable; Unstable
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-2546-2025 · Jul 18, 2025 · Open, ClassifiedBrand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, 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-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-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-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 PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 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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