NA 47-2357-004-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024088108), received between Nov 3, 2023 and Nov 3, 2023 — classified as 1 injury.

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

5 other recalls cover devices cleared under the same FDA submission (K042598, K111039); 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.

• InjuryNov 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANTED PLATE WAS FRACTURED AND WAS REMOVED FROM THE PATIENT. ATTEMPTS HAVE BEEN MADE AND THERE IS NO FURTHER INFORMATION AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 18064644 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042598, K111039. One submission often covers many models, so check the product and lot details in each record.

• Z-0311-2020 · Oct 10, 2019 · Terminated
  SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 47235802103 47235802104 47235802106 47235802108 47235802203 47235802204 47235802206 47235802208 47235
• Z-0310-2020 · Oct 10, 2019 · Terminated
  DIST LAT FEM LCK PLATE STERILE, Item Nos. 47235710106 47235710110 47235710114 47235710118 47235710122 47235710210 47235710214 47235710218 47235710222
• Z-0316-2020 · Oct 10, 2019 · Terminated
  PROX LAT HUMERAL LOCK PLATE, Item Nos. 47235800104 47235800106 47235800108 47235800112 47235800116 47235800204 47235800206 47235800208 47235800212
• Z-0309-2020 · Oct 10, 2019 · Terminated
  Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308 47235700310 47235700312 47235700314 47235700408 47235700410 47235700412 47235700414
• Z-0646-2016 · Dec 9, 2015 · Terminated
  Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length. Indicated for temporary in