NA 2347-20-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024051751), received between Jul 11, 2022 and Jul 11, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K142579); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2022Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF IMPLANTED PLATES APPROXIMATELY ONE (1) YEAR AFTER IMPLANTATION DUE TO SUCCESSFUL BONE HEALING. BEFORE REMOVAL, X-RAYS NOTICED TWO SCREWS HAD FRACTURED. SUBSEQUENTLY, DOCTOR DECIDED TO KEEP FRACTURED SCREWS IMPLANTED TO PREVENT DISTURBANCE TO HEALED BONE. PATIENT WAS NOT EXPERIENCING ANY HARM OR ADVERSE EFFECTS AS A RESULT OF THE FRACTURED SCREWS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 14982630 ↗
• MalfunctionJul 11, 2022Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT PATIENT UNDERWENT REMOVAL OF IMPLANTED PLATES APPROXIMATELY ONE (1) YEAR AFTER IMPLANTATION DUE TO SUCCESSFUL BONE HEALING. BEFORE REMOVAL, X-RAYS NOTICED TWO SCREWS HAD FRACTURED. SUBSEQUENTLY, DOCTOR DECIDED TO KEEP FRACTURED SCREWS IMPLANTED TO PREVENT DISTURBANCE TO HEALED BONE. PATIENT WAS NOT EXPERIENCING ANY HARM OR ADVERSE EFFECTS AS A RESULT OF THE FRACTURED SCREWS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Osteopenia/ Osteoporosis

  MAUDE report 14982623 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142579. One submission often covers many models, so check the product and lot details in each record.

• Z-0307-2020 · Oct 10, 2019 · Terminated
  Periarticular Plates - Tibial, Item Nos. 00234700304 00234700306 00234700308 00234700310 00234700312 00234700314 00234700316 00234700404 00234700406 00234700408 002347004
• Z-0315-2020 · Oct 10, 2019 · Terminated
  PERI DIST VOLAR/DORSAL T/DORSAL DELTA RADIAL, Item Nos. 00234801303 00234801304 00234801306 00234801308 00234801310 00234801312 00234801403 00234801404 00234801406 00234