StageOne SelectRecalls & reported problems across all models
Biomet Orthopedics, LLC · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 15
We found 15 models of StageOne Select by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2023 and May 20, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (1 report).
15 FDA recall records name at least one of these models by its device identifier.
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
StageOne Select 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.
- Feb 26, 2020Terminated
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Z-1652-2020 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2020Terminated
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Z-1651-2020 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2020Terminated
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Z-1650-2020 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2020Terminated
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Z-1649-2020 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2020Terminated
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Z-1648-2020 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2020Terminated
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Z-1647-2020 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2020Terminated
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Z-1646-2020 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2020Terminated
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Z-1645-2020 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2020Terminated
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Z-1644-2020 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2020Terminated
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Z-1643-2020 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2020Terminated
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Z-1642-2020 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2020Terminated
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Z-1641-2020 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2020Terminated
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Z-1640-2020 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2020Terminated
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Z-1639-2020 · Root cause: Process control · Recall details · FDA record ↗
- Feb 26, 2020Terminated
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Z-1638-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported StageOne Select problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
Patient problems
- Bone Fracture(s)1
- Pain1
StageOne Select models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- StageOne Select 431195Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 report
- StageOne Select 431190Prosthesis, hip, hemi-, femoral, metal1 recall1 report
- StageOne Select 431182Prosthesis, hip, hemi-, femoral, metal1 recall0 reports
- StageOne Select 431184Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- StageOne Select 431185Prosthesis, hip, hemi-, femoral, metal1 recall0 reports
- StageOne Select 431181Prosthesis, hip, hemi-, femoral, metal1 recall0 reports
- StageOne Select 431196Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- StageOne Select 431198Prosthesis, hip, hemi-, femoral, metal1 recall0 reports
- StageOne Select 431197Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- StageOne Select 431194Prosthesis, hip, hemi-, femoral, metal1 recall0 reports
- STAGEONE SELECT 431199Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- StageOne Select 431193Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- StageOne Select 431191Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
- StageOne Select 431192Prosthesis, hip, hemi-, femoral, metal1 recall0 reports
- StageOne Select 431183Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall0 reports
Recent StageOne Select adverse event reports
The 2 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED, APPROXIMATELY 8 MONTHS POSTOP, THE PATIENT PRESENTED WITH PERIPROSTHETIC INFECTION. A FIRST STAGE REVISION OCCURRED; ALL INITIAL IMPLANTS WERE REMOVED WITHOUT APPARENT COMPLICATION. AFTER REAMING THE FEMORAL CANAL, A NONDISPLACED FRACTURE IN THE PERITROCHANTERIC REGION WAS IDENTIFIED. AN UNKNOWN 3.5MM RECONSTRUCTION PLATE AND SCREWS WERE PLACED TO STABILIZE THE FRACTURE. NO FURTHER COMPLICATIONS WERE IDENTIFIED. FINAL INTRAOP X-RAYS INDICATED APPROPRIATE FRACTURE REDUCTION AND IMPLANT PLACEMENT. A CEMENT SPACER STEM WAS PLACED ALONG WITH AN ALL-POLY CUP, A CEMENTED CONSTRAINED LINER, AND ADDITIONAL SCREWS FOR FIXATION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.
Patient problems: Bone Fracture(s)
MAUDE report 25231005 ↗InjuryDec 6, 2023Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Pain
MAUDE report 18278146 ↗
Other Biomet Orthopedics, LLC products
- AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
- AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
- Compress Device71 models · 99 reports · 22 recalls
- Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- Comprehensive Shoulder System68 models · 191 reports · 11 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.
How reports and recalls are matched · Editorial policy · Report an error on this page