Variable Angle Locking Peg FDR 118Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840118110877), received between May 8, 2017 and May 8, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K123562); 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 18, 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.

• MalfunctionMay 8, 2017Nonstandard Device; Product Quality Problem; Defective Device; Nonstandard Device; Product Quality Problem; Defective Device

  WHILE IMPLANTING A DISTAL RADIUS PLATE(FDR 002, LOT 1609320008), THE LOCKING PEG (FDR 118, LOT 1611320073) WENT THROUGH THE PLATE. BOTH THE PLATE AND LOCKING PEG WAS REMOVED AND A NEW PLATE AND PEGS WERE PLACED IN THE BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6552946 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123562. One submission often covers many models, so check the product and lot details in each record.

• Z-0034-2022 · Sep 3, 2021 · Terminated
  Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
• Z-1314-2015 · Feb 16, 2015 · Terminated
  Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm