StablecutRecalls & reported problems across all models
Zimmer Orthopaedic Surgical Products, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 11 models of Stablecut by Zimmer Orthopaedic Surgical Products, Inc. in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Apr 17, 2023 and Mar 16, 2026 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (15 reports).
1 FDA recall record 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
Stablecut 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.
- Jul 27, 2018Terminated
Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.
Z-1676-2020 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported Stablecut problems
Device problems
- Delivered as Unsterile Product15
- Tear, Rip or Hole in Device Packaging4
- Unsealed Device Packaging4
- Break2
- Manufacturing, Packaging or Shipping Problem2
- Packaging Problem2
- Detachment of Device or Device Component1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
Stablecut models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Stablecut® 19075127YT1BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 recall0 reports
- Stablecut® 11-3583BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL16 reports
- Stablecut® 11-3586BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL4 reports
- Stablecut® 11-3501BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL2 reports
- Stablecut® 11-3539BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Stablecut® 11-3542BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Stablecut® 11-3584BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Stablecut® 11-3769BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Stablecut® 11-3785BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Stablecut® 11-4844BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
- Stablecut® 20090119AGCBLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL1 report
Recent Stablecut adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT DURING SURGERY, THE UNIT HAS A STERILIZATION OF SEAL ISSUE THAT NEEDS TO BE REVIEWED. THERE WAS NO PATIENT IMPACT OR DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24606739 ↗MalfunctionOct 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
THERE IS NO ADDITIONAL INFORMATION REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23278378 ↗MalfunctionOct 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
THERE IS NO ADDITIONAL INFORMATION REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23278365 ↗MalfunctionApr 22, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INSPECTION THE DEVICE HAD A FOREIGN SUBSTANCE IN THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21885094 ↗MalfunctionApr 2, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING SURGERY, THE PACKAGING WAS FOUND TO BE DAMAGED. THERE WAS NO PATIENT IMPACT OR DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21757653 ↗MalfunctionFeb 26, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE PACKAGING WAS WITHIN SPECIFICATIONS. IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR A REPORTABLE MALFUNCTION. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21469182 ↗MalfunctionFeb 4, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INSPECTION, THE UNIT WAS FOUND TO BE NONCONFORMING AS THERE WAS A FOREIGN SUBSTANCE ON IT. THERE IS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21307640 ↗MalfunctionJan 31, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT DURING INSPECTION, THE PRODUCT WAS FOUND TO BE NON CONFORMING AS THERE WAS WRINKLE IN THE SEALING AREA. THERE IS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21282032 ↗MalfunctionJan 29, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT DURING INCOMING INSPECTION THE PRODUCT WAS FOUND TO BE NON-CONFORMING AS THERE WAS A WRINKLE IN THE SEALING AREA. THERE IS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21268633 ↗MalfunctionJan 29, 2025Unsealed Device Packaging; Unsealed Device Packaging
DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE PACKAGING WAS WITHIN SPECIFICATIONS. IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR A REPORTABLE MALFUNCTION. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21268027 ↗MalfunctionNov 12, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INCOMING INSPECTION, ON AN UNKNOWN DATE, THE PRODUCT WAS FOUND TO BE NONCONFORMING AS A FOREIGN SUBSTANCE WAS NOTED IN THE PACKAGE. THERE IS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS IN PROGRESS AND NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20662793 ↗MalfunctionNov 4, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE PACKAGING WAS WITHIN SPECIFICATIONS. IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR A REPORTABLE MALFUNCTION. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20597911 ↗MalfunctionNov 4, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE PACKAGING WAS WITHIN SPECIFICATIONS. IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR A REPORTABLE MALFUNCTION. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20597889 ↗MalfunctionNov 4, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE PACKAGING WAS WITHIN SPECIFICATIONS. IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR A REPORTABLE MALFUNCTION. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20597785 ↗MalfunctionOct 9, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
NO ADDITIONAL EVENT INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20406370 ↗
Other Zimmer Orthopaedic Surgical Products, Inc. products
All Zimmer Orthopaedic Surgical Products, Inc. devices →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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