NA 2357-04-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00889024055537), received between Jun 7, 2022 and Jun 8, 2023 — classified as 1 injury, 3 malfunctions.

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

4 other recalls cover devices cleared under the same FDA submission (K042598, K141734); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT FELL AND THE GLENOSPHERE WAS DISLOCATED. THE BEARING WAS FOUND TO BE WORN. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Fall

  MAUDE report 17086011 ↗
• MalfunctionDec 14, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE STERILE PACKAGE WAS NOT VACUUMED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15976031 ↗
• MalfunctionSep 14, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGING WAS NOT VACUUMED PROPERLY. THIS ISSUE WAS FOUND AT THE DISTRIBUTORSHIP AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15419867 ↗
• MalfunctionJun 7, 2022Degraded; Degraded

  IT WAS REPORTED THAT THE ETCHING ON THE PRODUCT HAD WORN OFF. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14620424 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042598, K141734. One submission often covers many models, so check the product and lot details in each record.

• Z-2254-2023 · Jun 27, 2023 · Open, Classified
  Zimmer Periarticular Locking Plate (ZPLP) Distal Lateral Femoral Plate 6 holes 159 mm Length-Indicated for temporary internal fixation and stabilization of osteotomies and fracture
• Z-0317-2020 · Oct 10, 2019 · Terminated
  Periarticular locking plate elbow-sterile, Item Nos. 47235800503 47235800509 47235800511 47235800515 47235800519 47235800603 47235800605 47235800607 47235800609 472358006
• 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-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