Stablecut® 11-3583Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00889024494015), received between May 25, 2023 and Oct 15, 2025 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (7 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product7
- Unsealed Device Packaging4
- Tear, Rip or Hole in Device Packaging3
- Manufacturing, Packaging or Shipping Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions16
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
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 ↗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 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 ↗MalfunctionOct 9, 2024Unsealed Device Packaging; Unsealed Device Packaging
NO ADDITIONAL EVENT INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20406308 ↗MalfunctionApr 22, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING RECEIVING INSPECTION, THAT THE DEVICE'S PACKAGE WAS FOUND TO HAVE DEBRIS IN THE STERILE PACKAGING. THERE WAS NO HARM OR INJURY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19152122 ↗MalfunctionApr 11, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING INCOMING INSPECTION, DEVICE HAD WRINKLES IN THE SEAL AREA. THERE WAS NO PATIENT INVOLVEMENT OR IMPACT. DUE DILIGENCE INFORMATION COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19089532 ↗MalfunctionDec 19, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED SINCE THE WRINKLES IN LN 426749 WERE NOT RAISED AND DID NOT APPEAR TO COMPROMISE THE SEALS. THIS MEDWATCH IS BEING VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18357120 ↗MalfunctionDec 19, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED SINCE THE WRINKLES IN LN 426749 WERE NOT RAISED AND DID NOT APPEAR TO COMPROMISE THE SEALS. THIS MEDWATCH IS BEING VOIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18357118 ↗MalfunctionAug 14, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17540648 ↗MalfunctionMay 25, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17001443 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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