LCP 241.266Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982166272), received between Mar 8, 2018 and Mar 8, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

1 other recall cover devices cleared under the same FDA submission (K033995); 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 8, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A 3.5MM LOCKING COMPRESSION PLATE (LCP) POSTEROLATERAL DISTAL HUMERUS PLATE, 3.5MM CORTEX SCREWS (QUANTITY OF 3), 2.7MM LOCKING SCREWS (QUANTITY OF 2) AND 3.5MM LOCKING SCREWS (QUANTITY OF 4) FOR AN ORIF (OPEN REDUCTION INTERNAL FIXATION) OF A HUMERUS IN (B)(6) 2017. A NONUNION WAS NOTED ON AN UNKNOWN DATE. X-RAYS WERE TAKEN ON AN UNKNOWN DATE AND SHOWED THAT THE (TWO) 2.7MM LOCKING SCREWS WERE NOT CONNECTED TO THE PLATE. BOTH SCREWS WERE STUCK IN THE BONE FULLY INTACT, CAUSING MINIMAL FIXATION. THE X-RAYS ALSO SHOWED THAT THE THREADS ON ONE OF THE 2.7MM LOCKING SCREW HEADS STRIPPED. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2018. ALL HARDWARE WAS EASILY REMOVED. PATIENT WAS REVISED TO A VARIABLE ANGLE (VA) PLATE, SCREWS AND VIVIGEN FORMABLE BONE GRAFTS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: 3.5MM CORTEX SCREW, SELF-TAPPING 20MM (PART 204.820, LOT NUMBER UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW, SELF-TAPPING 24MM (PART 204.824 LOT NUMBER UNKNOWN, QUANTITY 1); 3.5MM CORTEX SCREW, SELF-TAPPING 28MM (PART 204.828 LOT NUMBER UNKNOWN,

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7325339 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033995. One submission often covers many models, so check the product and lot details in each record.

• Z-2278-2013 · Mar 8, 2013 · Terminated
  Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults