EVOS 72402015Recalls & reported problems
Smith & Nephew, Inc. · EVOS 2.0MM X 15MM CORTEX SCREW T6 SELF-TAPPING · Class 2 · Implant
All models of EVOS (190)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556425145), received between Aug 11, 2025 and Aug 11, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K140814, K210837, K213126); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) EVOS 2.0MM X 15MM CTX SCR T6 S-T BROKE IN THE SHAFT WHEN BEING TORQUED DOWN. ALL THE PIECES WERE REMOVED USING TWEEZERS AND ACCOUNTED. NO X-RAYS NOR SURGICAL NOTES ARE AVAILABLE. THE PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22775334 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K140814, K210837, K213126. One submission often covers many models, so check the product and lot details in each record.
- Z-2945-2020 · Aug 24, 2020 · TerminatedEVOS Screws - Product Usage: is a part of the EVOS MINI plating system, indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bones and s
- Z-0408-2018 · Nov 29, 2017 · Terminatedsmith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER 72442360N, NON-STERILE, Rx only, (01)00885556456446(10), (11)171116 Bone plates and bone screws from
Other PLATE, FIXATION, BONE devices
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- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive Specialized Orthopedics, Inc. · Plate, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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