GENESIS II 71440196Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010214409), received between Aug 3, 2020 and Feb 25, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII ALL POLY TIB IMPACTOR BROKE DOWN INTO SEVERAL PIECES ON LAST STROKE OF THE IMPACTOR WHEN IMPLANTING THE TIBIAL COMPONENT. INSTRUMENT WAS DISPOSED OFF INTO SHARPS BIN. NO PIECE FELL INSIDE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459242 ↗
• MalfunctionDec 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN IMPACTING THE POLY/TIBIA CONSTRUCT INTO THE PATIENT'S KNEE, THE BLACK IMPACTOR BLOCK OF THE GII ALL POLY TIB IMPACTOR BROKE IN TWO. NO FRAGMENTS IN PATIENT. ALL PARTS ACCOUNTED FOR. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY. NO DELAY OR INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21030905 ↗
• MalfunctionMay 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, ONE (1) GII ALL POLY TIB IMPACTOR FRACTURED UPON IMPACTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. ALL PIECES WERE RECOVERED, AND NO PATIENT HARM WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19367265 ↗
• MalfunctionNov 18, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A LARGE PIECE OF A GII ALL POLY TIB IMPACTOR BROKE OFF. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18166930 ↗
• MalfunctionAug 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII ALL POLY TIB IMPACTOR BROKE WHILE IMPACTING THE TIBIAL TRAY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17466940 ↗
• MalfunctionMar 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII ALL POLY TIB IMPACTOR DEVICE BROKE INTO TWO PIECES AND BOTH PIECES WERE RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16531488 ↗
• MalfunctionSep 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT A GII ALL POLY TIB IMPACTOR WAS FOUND BROKEN. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393436 ↗
• MalfunctionMay 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, AFTER A TKA PROCEDURE, THE SCREW WHERE THE BLACK PIECE OF THE GII ALL POLY TIB IMPACTOR AND THE SHAFT CONNECT, CAME OUT. THE HEAD OF THE IMPACTOR SWIVELS AROUND AND IS LOOSE. AS THIS HAPPENED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14307738 ↗
• MalfunctionFeb 3, 2022Break; Break

  IT WAS REPORTED THAT, A GII ALL POLY TIB IMPACTOR BROKE IN HALF. AS THIS WAS NOTICED DURING A FIELD INSPECTION THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446456 ↗
• MalfunctionAug 4, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A GII ALL POLY TIB IMPACTOR IS LOOSE. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12276665 ↗
• MalfunctionJul 12, 2021Fracture; Fracture

  IT WAS REPORTED THAT, THE HEAD OF A GII ALL POLY TIB IMPACTOR HAS A CRACK ON IT. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12155116 ↗
• MalfunctionJun 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING TKA SURGERY, A PIN OF THE GENESIS II ALL POLY TIB IMPACTOR CAME OUT WHILE INSTRUMENTS WERE OUTSIDE THE PATIENT. SURGERY/TREATMENT WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12082358 ↗
• MalfunctionMay 11, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII ALL POLY TIB IMPACTOR BROKE DURING IMPACTION. THE INSTRUMENT WAS OUTSIDE OF THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY WITH THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807776 ↗
• MalfunctionMar 1, 2021Crack; Crack

  IT WAS REPORTED THAT THE IMPACTOR CRACKED DURING STERILIZATION PROCESS, IT WAS DISCOVERED DURING POST-SURGERY INSTRUMENT INSPECTION. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391222 ↗
• MalfunctionOct 8, 2020Crack; Crack

  IT WAS REPORTED THAT IMPACTOR CRACKED WHEN IT WAS STERILIZED. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10651052 ↗
• MalfunctionAug 3, 2020Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE TKA AFTER IMPACTING THE TIBIA, ALL POLY IMPACTOR WAS BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10354583 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116