Alliance® SBGL5001Recalls & reported problems
Zimmer, Inc. · Class 2
All models of Alliance (32)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00889024574854), received between Jan 11, 2022 and Aug 21, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Fracture” (16 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.
Reports received per month
Most reported problems
Device problems
- Fracture16
- Crack4
Patient problems
- No Clinical Signs, Symptoms or Conditions17
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2026Fracture
It was reported during the procedure, it was discovered the instrument had a cracked tip that was about to break. The proper surgical technique was utilized. There was no patient injury or delay in procedure. Attempts have been made and no further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50371504 ↗MalfunctionJul 1, 2026Crack; Fracture
IT WAS REPORTED THAT UPON ROUTINE INSPECTION AFTER THE INSTRUMENTS CAME THROUGH THE WASHER IT WAS NOTED THAT THE GLENOID IMPACTOR ALSO CRACKS AND NEEDED REPLACEMENTS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25680260 ↗MalfunctionMar 16, 2026Fracture
IT WAS REPORTED THE IMPACTOR BROKE WHILE IMPLANTING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A SECONDARY DEVICE. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REPORTED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24605139 ↗MalfunctionMar 2, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482864 ↗MalfunctionDec 12, 2025Crack; Fracture; Crack; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23791165 ↗MalfunctionApr 22, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE IMPACTOR CRACKED DOWN THE MIDDLE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21882260 ↗MalfunctionNov 26, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20788662 ↗MalfunctionNov 26, 2024Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS IMPACTING THE GLENOID IMPLANT THE BLUE TIP OF THE INSTRUMENT FRACTURED OFF. THE TIP FELL ON THE FLOOR AND NO PIECES FELL INTO THE PATIENT. THERE WAS NO REPORT OF FOREIGN BODY RETAINED OR HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20788449 ↗MalfunctionNov 26, 2024Crack; Crack
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20777406 ↗MalfunctionOct 2, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20352421 ↗MalfunctionMar 5, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18836964 ↗MalfunctionMay 10, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16904834 ↗MalfunctionFeb 21, 2023Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENT BROKE. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16409355 ↗MalfunctionJan 13, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16158399 ↗MalfunctionDec 22, 2022Fracture; Fracture
IT WAS REPORTED THAT THE HEAD OF THE IMPACTOR BROKE IN HALF WHILE IMPACTING THE GLENOID. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16038690 ↗MalfunctionJun 21, 2022Crack; Fracture; Crack; Fracture
IT WAS REPORTED THAT THE TIP ON IMPACTOR WAS CRACKED. IT WAS NOTICED AFTER THE CASE CAME OUT OF THE WASH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14754799 ↗MalfunctionJan 11, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE IMPACTOR WAS BROKEN AFTER RECEIVING IT FROM WASH IN STERILE PROCESSING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13225895 ↗
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- 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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