Alliance® SBGL2000Recalls & reported problems
Zimmer, Inc. · Class 2
All models of Alliance (32)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Zimmer Alliance shoulder implant system is used to replace the shoulder's ball-and-socket joint. Most of the 38 reports describe the bone breaking around the implant, plus handles and screws coming loose or breaking during surgery; 5 injuries and no deaths were reported. No recalls name this device. Reports dropped from 19 in the prior 12 months to 11.
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
- 38
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00889024574632), received between Sep 13, 2023 and Sep 30, 2026 — classified as 5 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Fracture” (33 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture33
- Detachment of Device or Device Component2
- Break1
- Difficult to Insert1
- Naturally Worn1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- Foreign Body In Patient3
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Positioning Failure; Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954200 ↗MalfunctionAug 31, 2026Detachment of Device or Device Component
It was reported that the screw disengaged from the blue vault guide handle while the instrument was being used as a glenoid targeting guide, and a second handle was obtained to continue the procedure. During cleaning after the procedure, the screw, which had been safely retained from the patient and operative site, was subsequently lost in the washer. 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 50532281 ↗MalfunctionApr 23, 2026Fracture
IT WAS REPORTED THE GLENOID HANDLE DID NOT CLIP OR HOLD THE SIZER AND WAS DISCOVERED TO BE FRACTURED UPON INVESTIGATION. 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 24973191 ↗MalfunctionApr 8, 2026Break
IT WAS REPORTED THAT THE INSTRUMENT WAS NOT FUNCTIONING PROPERLY OR BROKE DURING SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24815950 ↗MalfunctionMar 13, 2026Fracture
IT WAS REPORTED THAT THE LOCKING MECHANISM IN A GLENOID GUIDE INSERTER HANDLE BROKE. 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 24590535 ↗MalfunctionFeb 18, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT A SIZER HANDLE WAS DISASSEMBLED DURING A PROCEDURE, WITH NO PATIENT HARM OR IMPACT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24382854 ↗MalfunctionFeb 16, 2026Fracture; Naturally Worn
IT WAS REPORTED THE INNER CAPTURE OF THE GLENOID SIZER HANDLE HAD WORN AWAY AND BROKE WHILE TRYING TO ATTACH IT TO THE IMPLANT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN ALTERNATE DEVICE AND NO PATIENT HARM WAS REPORTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24344672 ↗InjuryDec 23, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 23879456 ↗MalfunctionDec 23, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23879202 ↗MalfunctionNov 24, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23638326 ↗MalfunctionNov 14, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23558571 ↗InjuryOct 17, 2025Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT WHEN THE SURGEON ATTEMPTED TO USE THE INSTRUMENT, THE TIP OF THE HANDLE DOES NOT LOCK IN PLACE. THERE WAS NO REPORT OF HARM TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER EVENT INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23323305 ↗MalfunctionOct 8, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23245085 ↗MalfunctionAug 1, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22686546 ↗MalfunctionJun 26, 2025Fracture; Fracture
IT WAS FURTHER REPORTED THAT NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. 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 22337547 ↗MalfunctionJun 16, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE INSTRUMENT DURING THE SURGICAL PROCEDURE, THE TIP OF THE INSTRUMENT FRACTURED. THE TIP FRACTURED AFTER DRILLING ALL THE PERIPHERAL HOLES, SO IT DID NOT AFFECT THE CASE. THERE WAS NO REPORT OF A FOREIGN BODY RETAINED OR HARM TO THE PATIENT. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22212689 ↗MalfunctionJun 2, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING SETUP FOR THE SURGICAL PROCEDURE THE PIN FRACTURED IN THE INSTRUMENT. THERE WAS NO FOREIGN BODY RETAINED OR HARM TO THE PATIENT AS THIS OCCURRED ON THE BACK TABLE AND NOT NEAR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22126248 ↗MalfunctionMay 15, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22032487 ↗MalfunctionApr 4, 2025Fracture; Fracture
NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21772984 ↗MalfunctionMar 24, 2025Fracture; Fracture
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21676873 ↗MalfunctionMar 10, 2025Fracture; Fracture
IT WAS REPORTED THAT THE INSTRUMENT WAS FRACTURED. THERE WAS NO REPORT OF A FOREIGN BODY RETAINED OR HARM TO THE PATIENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21560354 ↗MalfunctionJan 23, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21223841 ↗MalfunctionJan 6, 2025Fracture; Fracture
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21081368 ↗MalfunctionJan 6, 2025Fracture; Fracture
IT WAS REPORTED THAT DURING SURGERY THAT THE GLENOID SIZING HANDLE DOESN¿T HOLD THE SIZER. PHOTOGRAPH OF THE DEVICE INDICATES THAT IT IS FRACTURED. THERE WAS NO HARM, INJURY, SURGICAL/MEDICAL INTERVENTION TO PATIENT AND NO RECORD OF A DELAY. DUE DILIGENCE IS IN PROGRESS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21081311 ↗MalfunctionDec 31, 2024Fracture; Fracture
IT WAS REPORTED THAT THE SIZING HANDLE WAS BROKEN DURING A PROCEDURE. NO PATIENT HARM WAS REPORTED AS A RESULT. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21048842 ↗
Other PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED devices
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-36-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls27 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 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 16, 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