VERSA DIAL(TM) SHOULDER SYSTEM 407297Recalls & reported problems
Biomet Orthopedics, LLC · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00880304456679), received between Jan 4, 2022 and May 13, 2026 — classified as 1 injury, 16 malfunctions.
The most frequently reported specific device problem is “Fracture” (15 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
- Fracture15
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Failure of Implant1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Break
IT WAS REPORTED THAT THE INSTRUMENT WAS NOT FUNCTIONING PROPERLY OR BROKE DURING SURGERY. THE ISSUE WAS IDENTIFIED INTRA-OPERATIVELY DURING INSTRUMENT USE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162997 ↗MalfunctionMay 11, 2026Fracture
IT WAS REPORTED THAT THE HEAD IMPACTOR BROKE WHILE FINISHING IMPLANTING THE HEAD. NO PATIENT IMPACT WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25138882 ↗MalfunctionMar 2, 2026Fracture
IT WAS REPORTED THAT DURING AN INITIAL SHOULDER PROCEDURE, A HUMERAL HEAD IMPACTOR INSTRUMENT BROKE WHILE BEING USED TO IMPACT THE HUMERAL HEAD COMPONENT. THE EVENT WAS IDENTIFIED INTRAOPERATIVELY DURING IMPACTION. THE SURGICAL TECHNIQUE SPECIFIED FOR THE PROCEDURE WAS REPORTED TO BE FOLLOWED. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED AS A RESULT OF THIS MALFUNCTION. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24484803 ↗MalfunctionDec 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 23688296 ↗MalfunctionJun 3, 2025Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE INSTRUMENT TO IMPACT THE GLENOSPHERE THE TIP OF THE INSTRUMENT FRACTURED. A BACK UP INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF FOREIGN BODY RETAINED OR HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22135117 ↗MalfunctionFeb 19, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE IMPACTOR BROKE. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21412133 ↗MalfunctionFeb 11, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21356062 ↗MalfunctionNov 13, 2024Fracture; Fracture
IT WAS REPORTED THAT WHILE THE SURGEON WAS USING THE INSTRUMENT IT FRACTURED. THERE WAS NO REPORT OF A FOREIGN BODY RETAINED OR HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20675817 ↗MalfunctionAug 15, 2024Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE IMPACTOR BROKE WHILE IMPACTING THE HUMERAL HEAD. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19990604 ↗MalfunctionMay 27, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, THE IMPACTOR TIP FRACTURED DURING IMPACTION. THE CORRECT SURGICAL TECHNIQUE WAS USED. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. THE CASE WAS COMPLETED WITH A BACKUP DEVICE 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 19402157 ↗MalfunctionDec 15, 2023Fracture; Fracture
IT WAS REPORTED THAT THE IMPACTOR TIP FRACTURED DURING AN INITIAL SHOULDER SURGERY. THIS FRACTURE OCCURRED WHEN THE SURGEON IMPACTED THE HEAD ONTO THE STEM, AND NO FRAGMENTS REMAINED IN THE PATIENT. THE CORRECT SURGICAL TECHNIQUE WAS USED AND ANOTHER IMPACTOR FROM A REVERSE TRAY WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED 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 18336338 ↗MalfunctionMar 29, 2023Fracture; Fracture
IT WAS REPORTED THAT THE SURGEON WAS IMPACTING A DEFINITIVE VERSA-DIAL HEAD WHEN THE IMPACTOR TIP SPLIT IN HALF. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16637261 ↗MalfunctionFeb 9, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16335625 ↗MalfunctionMay 10, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE IMPACTOR FRACTURED DURING THE SURGERY AFTER HAMMERING IN THE IMPLANT. NO ADVERSE EVENT HAS BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14348073 ↗InjuryFeb 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 7 MONTHS POSTIMPLANTATION DUE TO DISASSOCIATION OF THE BASEPLATE AND TAPER ADAPTOR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 13558884 ↗MalfunctionFeb 14, 2022Fracture; Fracture
IT WAS REPORTED THAT THE IMPACTOR TIP BROKE WHILE IMPACTING THE GLENOSPHERE INTO BASEPLATE. 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 13524341 ↗MalfunctionJan 4, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TIP OF THE INSTRUMENT FELL OFF. IMAGES THAT WERE TAKEN SHOW THAT THE TIP FRACTURED OFF OF THE INSTRUMENT. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13156275 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 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.
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