EVOS 72412716NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556451694), received between Mar 10, 2021 and Mar 10, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ANKLE ORIF SURGERY, WHEN TAKING THE FINAL X-RAY PICTURES OF THE FRACTURE, IT WAS NOTED THAT A 2.7MM LOCKING SCREW THAT WAS ENGAGED INTO THE EVOS LATERAL DISTAL FIBULA PLATE, WAS FOUND TO BE TOO LONG AND INVADING THE JOINT. IT WAS DECIDED TO EXCHANGE THE SCREW TO A SHORTER ONE. WHEN USING THE T8 DRIVER TO REMOVE THE SCREWS, IT STRIPPED AND SCREWS WERE NO POSSIBLE TO BE REMOVED. A HIGH SPEED BURR WAS USED TO REMOVE THE SURROUNDING PLATE AROUND THE STRIPPED SCREW HEAD IN ORDER TO HAVE ACCESS TO PLACE A PAIR OF MULTI GRIPS OVER THE SCREW HEAD AND THEN IT WAS REMOVED. A DELAY GREATER THAN 30 MINUTES OCCURRED DUE TO THIS EVENT. NO INJURIES TO PATIENT ERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11449953 ↗

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 · Terminated
  EVOS 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 · Terminated
  smith&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