SCP® Foot & Ankle Kit 514.503Recalls & reported problems
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024205376), received between Dec 22, 2020 and Oct 14, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Improper Chemical Reaction” (2 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 18, 2026.
Most reported problems
Device problems
- Improper Chemical Reaction2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 14, 2022Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED THAT DURING A PROCEDURE THE PRODUCT WOULD NOT MIX. THE CASE WAS ABORTED, AND THE PATIENT DID NOT RECEIVE TREATMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15607327 ↗InjuryOct 14, 2022Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED THAT DURING A PROCEDURE THE PRODUCT WOULD NOT MIX. THE CASE WAS ABORTED, AND THE PATIENT DID NOT RECEIVE TREATMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15607181 ↗InjuryDec 22, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 11059144 ↗
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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