SMARTLOCK 52-20504Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 34546540355677), received between Oct 8, 2025 and Oct 8, 2025 — classified as 2 malfunctions.

1 other recall cover devices cleared under the same FDA submission (K014263); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLATE WAS DAMAGED POSTOPERATIVELY AND NEEDS TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23247271 ↗
• MalfunctionOct 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLATE WAS DAMAGED POSTOPERATIVELY AND NEEDS TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23247269 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K014263. One submission often covers many models, so check the product and lot details in each record.

• Z-0610-2009 · Sep 19, 2008 · Terminated
  Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate, Straight, w. Template, Stryker Leibinger GmbH & Co., Freiburg, Germany; REF # 55-28911. A mandib