Variable Angle Locking Screw FRP 316Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840118100823), received between Jun 5, 2018 and Jun 5, 2018 — classified as 1 injury.

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

• InjuryJun 5, 2018Fracture; Fracture

  THE ORIGINAL SURGERY FOR THE IMPLANTATION OCCURRED ON (B)(6) 2017. THE LOCKING SCREW WAS SHOWN AS FRACTURED WITHIN THE X-RAY. THE BONE WAS NOT FUSED. THE MALUNION IS AN INHERENT RISK OF SURGERY. THE REVISION SURGERY OCCURRED ON (B)(6) 2018.

  Patient problems: Joint Dislocation; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7570229 ↗

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