Alliance® SBGL3007Recalls & reported problems
Zimmer, Inc. · Class 2
All models of Alliance (32)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Zimmer Alliance shoulder prosthesis is a metal and polymer shoulder replacement system. Of the 161 reports, 156 are malfunctions, and most describe reamers used in surgery that crack, fracture, or wear. The reports include no deaths and 5 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 162
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 162 adverse event reports that list this exact device (DI 00889024574779), received between Feb 2, 2021 and Sep 15, 2026 — classified as 6 injuries, 156 malfunctions.
The most frequently reported specific device problem is “Fracture” (141 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
- Fracture141
- Crack18
- Naturally Worn6
- Material Twisted/Bent5
- Material Split, Cut or Torn4
- Mechanical Jam2
- Difficult to Insert1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions157
- Foreign Body In Patient4
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 162 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Fracture
It was reported that a Steinmann pin broke off inside the glenoid during reaming for the post in an intra-operative shoulder procedure.Attempts have been made and no further information has been provided.
Patient problems: Foreign Body In Patient
MAUDE report 50776708 ↗MalfunctionJul 10, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25778561 ↗MalfunctionJul 8, 2026Fracture
IT WAS REPORTED THAT A POST REAMER BECAME DAMAGED DURING REAMING OF THE GLENOID. THE DAMAGE OCCURRED WHILE REAMING EXCESSIVELY HARD GLENOID BONE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25747223 ↗MalfunctionJul 1, 2026Crack; Fracture
IT WAS REPORTED THAT UPON ROUTINE INSPECTION AFTER THE INSTRUMENTS CAME THROUGH THE WASHER IT WAS NOTED THAT THE TIP OF THE REAMER HAD CRACKS IN IT AND NEEDED REPLACEMENTS. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25680141 ↗MalfunctionJun 3, 2026Fracture
IT WAS REPORTED THAT TWO REAMERS FROM A LOANER KIT WERE IDENTIFIED AS DAMAGED, WITH THE TIPS CRACKED AND WORN. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25381529 ↗MalfunctionJun 2, 2026Fracture
IT WAS REPORTED THAT A CENTRAL POST REAMER SPLIT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25361230 ↗MalfunctionJun 1, 2026Fracture
IT WAS REPORTED THAT TWO REAMERS FROM A LOANER KIT WERE IDENTIFIED AS DAMAGED, WITH THE TIPS CRACKED AND WORN. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350073 ↗MalfunctionMay 22, 2026Fracture
IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, THE REAMER FRACTURED. THE CORRECT SURGICAL TECHNIQUE WAS USED. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED AS A RESULT OF THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25252702 ↗MalfunctionMar 16, 2026Insufficient Device Problem Information
IT WAS REPORTED THERE WAS AN UNKNOWN ISSUE WITH THE REAMER. INVESTIGATION RESULTS NOTED THAT THE REAMER IS WORN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24609679 ↗MalfunctionMar 10, 2026Fracture
IT WAS REPORTED THAT THE DEVICE BROKE DURING SURGERY. ANOTHER DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24560261 ↗MalfunctionFeb 19, 2026Naturally Worn
IT WAS REPORTED THAT DURING A PROCEDURE, THE REAMER TEETH WERE NOTED TO BE EXPANDING OUT. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24392125 ↗MalfunctionFeb 6, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24285090 ↗MalfunctionFeb 3, 2026Fracture
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE CENTRAL REAMER SPLIT AT THE TOP. THE EVENT OCCURRED INTRAOPERATIVELY WHILE THE DEVICE WAS IN USE, AND THE REPORTER NOTED THAT THE DEVICE HAD BEEN USED IN A PRIOR SURGERY. NO FRAGMENTS FELL INTO THE PATIENT, AND THE PROCEDURE WAS COMPLETED; HOWEVER, THE DEVICE WAS DEEMED UNSUITABLE FOR SUBSEQUENT USE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24252716 ↗MalfunctionFeb 3, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24243990 ↗MalfunctionJan 30, 2026Crack; Fracture
IT WAS REPORTED THE MODULAR CENTER POST REAMER TIP WAS FOUND CRACKED AFTER THE PROCEDURE. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REPORTED, AND NO FOREIGN BODIES WERE REPORTED RETAINED DUE TO THIS MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24225600 ↗MalfunctionJan 20, 2026Fracture
IT WAS REPORTED THAT THE GLENOID CENTRAL REAMER FRACTURED DURING A PROCEDURE. THE PIECE BROKE OFF INTO THE PATIENT, BUT WAS SUCCESSFULLY RETRIEVED. THE CORRECT SURGICAL TECHNIQUE WAS USED AND THE CASE WAS COMPLETED WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24123754 ↗MalfunctionJan 7, 2026Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23990583 ↗MalfunctionJan 6, 2026Fracture
IT WAS REPORTED THE MODULAR CENTER POST REAMER TIP WAS COMPLETELY DAMAGED AFTER REAMING. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REPORTED, AND NO FOREIGN BODIES WERE REPORTED RETAINED DUE TO THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23976829 ↗MalfunctionJan 5, 2026Naturally Worn
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23967827 ↗MalfunctionJan 5, 2026Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23958482 ↗MalfunctionDec 31, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23936027 ↗MalfunctionDec 22, 2025Crack; Fracture; Crack; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23872404 ↗MalfunctionDec 22, 2025Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn
IT WAS REPORTED THAT A GUIDE PIN BECAME STUCK IN A POST REAMER, RESULTING IN A SPLIT AT THE TIP OF THE REAMER. IT WAS ADDITIONALLY REPORTED THAT THE SURGERY WAS COMPLETED WITH A BACKUP REAMER. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23872149 ↗MalfunctionDec 12, 2025Crack; Fracture; Crack; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23788966 ↗MalfunctionDec 10, 2025Crack; Crack
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23767444 ↗
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
- 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
- DELTA XTEND 130790024Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED122 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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