FIXOS CS24ARecalls & reported problems
Stryker GmbH · Cannulated self-tapping compression screw · Class 2 · Implant
All models of FIXOS (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252259077), received between Aug 27, 2019 and Aug 8, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- Device Embedded In Tissue or Plaque1
- Implant Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PRESENT SWISS TRAUMA FRACTURE REGISTRY (SWTR) IS A PROSPECTIVE, MULTI-CENTER, OBSERVATIONAL STUDY TO COLLECT DATA ON ALL STRYKER TRAUMA AND EXTREMITIES PRODUCTS WITH THE AIM TO ADD TO THE EXISTING CLINICAL EVIDENCE TO SUPPORT THE SAFETY AND PERFORMANCE OF STRYKER IMPLANTS FOR THE APPROVED INDICATIONS FOR USE. THE SWTR CAPTURES DATA EVALUATING THE REAL-WORLD USAGE OF STRYKER IMPLANTS AT TRAUMA CENTERS WITH THE CAPACITY, TRAINING, AND EXPERIENCE TO GATHER CLINICALLY RELEVANT STANDARD OF CARE SAFETY AND PERFORMANCE ENDPOINT DATA. DURING THE REVIEW OF THE REPORT, PERSISTENT PAIN WAS NOTED FOR THIS PATIENT DURING THE FOLLOW-UP VISIT.
Patient problems: Implant Pain
MAUDE report 19938130 ↗MalfunctionAug 27, 2019Fracture; Detachment of Device or Device Component; Fracture
IT WAS REPORTED THAT DURING FIXATION OF AN MTP, THE HEAD OF THE FIXOS CS24A SCREW SHEARED OFF OF THE SCREW. THE DISTAL END OF THE SCREW WAS LEFT IN THE PATIENT. IT WAS FURTHER REPORTED THAT THE SURGEON DID NOT PRE-DRILL THE BONE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR ADVERSE CONSEQUENCES REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8935587 ↗
Other Screw, fixation, bone devices
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- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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