NA 72200675Recalls & reported problems
Smith & Nephew, Inc. · EUR/UK LATERAL RAIL CLAMPS 2 0.394 INCH X 0.984 INCH 1 CM X 2.6 CM, 0.250 INCH X 1.250 INCH 1 CM X 2.6 CM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010595362), received between Mar 11, 2021 and Mar 11, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 16, 2026.
Most reported problems
Device problems
- Device Markings/Labelling Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT IT WAS FOUND THAT WHEN THE WAREHOUSE PRINTED THE EUR/UK RAIL CLAMP (LATERL DSTRCTR SYS) LABEL, THE OUTER BOX INFORMATION WAS NOT CONSISTENT WITH THE ACTUAL PRODUCT BECAUSE THERE WAS ONLY ONE SN NUMBER ON THE OUTER BOX INFORMATION, AND THERE ARE TWO SN NUMBER ON THE REAL OBJECT INSIDE. THERE WAS NO CASE REPORTED, THEREFORE THERE WAS NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11467896 ↗MalfunctionMar 11, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT IT WAS FOUND THAT WHEN THE WAREHOUSE PRINTED THE EUR/UK RAIL CLAMP (LATERL DSTRCTR SYS) LABEL, THE OUTER BOX INFORMATION WAS NOT CONSISTENT WITH THE ACTUAL PRODUCT BECAUSE THERE WAS ONLY ONE SN NUMBER ON THE OUTER BOX INFORMATION, AND THERE ARE TWO SN NUMBER ON THE REAL OBJECT INSIDE. THERE WAS NO CASE REPORTED, THEREFORE THERE WAS NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11467894 ↗
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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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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