Vanguard Knee System 189260Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304448490), received between May 8, 2024 and May 8, 2024 — classified as 1 injury.

1 FDA recall record name this device's identifier.

6 other recalls cover devices cleared under the same FDA submission (K060525, K171054); 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.

Recalls naming this device

1. Apr 17, 2020Terminated

   Potential presence of elevated endotoxin levels that exceed the specification limit

   Z-2151-2020 · Root cause: Process control · FDA record ↗

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.

• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING SHORTNESS OF BREATH AND BLOOD CLOT TWO MONTHS POST IMPLANTATION. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19270989 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060525, K171054. One submission often covers many models, so check the product and lot details in each record.

• Z-2152-2020 · Apr 17, 2020 · Terminated
  Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM 189442 Vanguard Knee
• Z-0938-2019 · Dec 21, 2018 · Terminated
  Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
• Z-2289-2018 · May 24, 2018 · Terminated
  Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthropla
• Z-2177-2018 · May 18, 2018 · Terminated
  Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total
• Z-2183-2018 · May 11, 2018 · Terminated
  Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
• Z-1861-2017 · Feb 17, 2017 · Terminated
  various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Pa