Variable Angle Locking Screw FRP 318Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840118100830), received between Sep 29, 2022 and Sep 29, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• MalfunctionSep 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED ON (B)(6) 2022 FOR AN EXPIRED IMPLANT (FRP 318 000 SCREW) THAT WAS IMPLANTED (EXPIRY DATE 2022-04).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15501137 ↗

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