AllianceRecalls & reported problems across all models
Zimmer, Inc. · 32 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Alliance model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 275
- Deaths reported
- 1
- Injuries reported
- 40
- Recalls
- 2
We found 32 models of Alliance by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 275 adverse event reports in the FDA's MAUDE database, received between Feb 2, 2021 and Sep 30, 2026 — classified as 1 death, 40 injuries, 234 malfunctions.
The most frequently reported specific device problem is “Fracture” (222 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Alliance recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 20, 2026Open, Classified
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Z-2531-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 20, 2026Open, Classified
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Z-2530-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Alliance problems
Device problems
- Fracture222
- Crack22
- Naturally Worn16
- Adverse Event Without Identified Device or Use Problem15
- Material Twisted/Bent5
- Material Split, Cut or Torn4
- Detachment of Device or Device Component3
- Device Dislodged or Dislocated2
Patient problems
- No Clinical Signs, Symptoms or Conditions238
- Foreign Body In Patient8
- Insufficient Information8
- Pain8
- Failure of Implant4
- Bone Fracture(s)3
- Erosion3
- Hematoma3
Alliance models
32 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Alliance® SBGL3007PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- Alliance 110040444Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 recall1 report
- Alliance 110040476Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 recall1 report
- Alliance® SBGL2000PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED38 reports
- Alliance® SBGL5001PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED17 reports
- Alliance® SBGL3701PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED11 reports
- Alliance® SBGL6044PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED7 reports
- Alliance™ SAGL2043PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED6 reports
- Alliance™ SAGL2032PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED3 reports
- Alliance™ SAGL2023PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 death2 reports
- Alliance™ SAGL2042PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Alliance® SBGL6042PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Alliance® SBGL6043PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Alliance™ SAGL2044PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Alliance™ SAGL2045PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED2 reports
- Alliance™ SAGL2024PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Alliance™ SAGL2035PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Alliance™ SAGL2044PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Alliance™ SAGL2045PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Alliance™ SAGP0001PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Alliance® SBGL3004PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Alliance® SBGL3005PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Alliance® SBGL6045PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Alliance® SBGL6033PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Alliance® SBGL3702PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Alliance® SBGL3704PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Alliance® SBGL3705PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Alliance™ SAGL2022PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Alliance™ SAGL2042PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Alliance™ SAGL2043PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Alliance™ SAGL2144PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
- Alliance™ SAGL2242PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 report
Recent Alliance adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗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 ↗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 ↗InjuryAug 6, 2026Degraded
It was reported that during a follow-up examination, radiographs showed that the glenoid post and glenoid component had completely dissolved. Attempts have been made and no further information has been provided.
Patient problems: Insufficient Information
MAUDE report 50165705 ↗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 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 ↗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 16, 2026Fracture
IT WAS REPORTED THAT THE PERIPHERAL POST OF A SIZE 4 GLENOID TRIAL BROKE DURING REMOVAL FROM BONE, AND THE BROKEN PIECE WAS RETRIEVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25520573 ↗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 ↗InjuryMay 29, 2026Fracture
IT WAS REPORTED THAT A PORTION OF THE AUGMENT REAMER DRIVER FRACTURED INSIDE THE PATIENT DURING A PROCEDURE. AN ADDITIONAL INCISION WAS MADE IN ORDER TO REMOVE THE FRACTURED PORTION. ATTEMPTS HAVE BEEN MADE AN NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25331779 ↗MalfunctionMay 22, 2026Fracture
IT WAS REPORTED THAT DURING REAMING FOR AN AUGMENT, THE TIP OF THE REAMER DRIVER SHEARED OFF INTO THE AUGMENT REAMER. DURING INTRA-OPERATIVE PREPARATION, WHILE THE SURGEON WAS REAMING FOR AN AUGMENT, THE OFF-AXIS REAMER TIP FRACTURED AND REMAINED WITHIN THE AUGMENT REAMER ASSEMBLY. THE SURGEON HAD COMPLETED THE REAMING PORTION AND WAS ABLE TO FINISH THE CASE AS PLANNED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25256116 ↗
Other Zimmer, Inc. products
- PERSONA364 models · 2,000 reports · 3 recalls
- Persona The Personalized Knee77 models · 1,396 reports
- PERSONA Vivacit-E285 models · 1,152 reports
- NexGen198 models · 842 reports · 4 recalls
- Affixus18 models · 1 reports · 17 recalls
- PERSONA Natural Tibia25 models · 417 reports · 2 recalls
- NexGen Legacy119 models · 319 reports · 3 recalls
- Comprehensive18 models · 103 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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