EVOS 72440506Recalls & reported problems
Smith & Nephew, Inc. · EVOS 3.5MM LOCKING 1/3 TUBULAR PLATE 6 HOLE 70MM · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556639788), received between Aug 8, 2024 and Aug 8, 2024 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K162078, 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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Nonunion/Delayed-union Bone Fracture1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 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
IT WAS REPORTED THAT, FOLLOWING A TIBIAL ORIF PROCEDURE PERFORMED BEFORE (B)(6) 2020 TO REDUCE A BICONDYLAR TIBIAL PLATEAU FRACTURE, ONE (1) PATIENT DEVELOPED AN INFECTED NONUNION THAT REQUIRED THE REMOVAL OF ALL HARDWARE. THE FRACTURE WAS REPORTEDLY REDUCED AT SIXTEEN (12) POSTOPERATIVE WEEKS. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Nonunion/Delayed-union Bone Fracture; Unspecified Infection
MAUDE report 19945178 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K162078, K210837, K213126. One submission often covers many models, so check the product and lot details in each record.
- Z-0265-2022 · Oct 25, 2021 · Open, ClassifiedSmith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- 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 STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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