LEGION 71434424Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010549327), received between Mar 28, 2019 and Oct 2, 2023 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

4 other recalls cover devices cleared under the same FDA submission (K121393); 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2023Break; Break

  IT WAS REPORTED THAT DURING TKA SURGERY, THE SPRING OF ONE (X1) LGN HOUSING RESECT COLLET S3-8 BROKE WHILE REAMING. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT 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 17851627 ↗
• MalfunctionOct 19, 2022Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT AN LGN HOUSING RESECT COLLET S3-8 HAD BECOME STUCK ON THE BOX CHISEL INSTRUMENT, DUE TO IT SPLINTERING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, BY USING A DOUBLE ACTION NIBBLER. NOTHING FELL IN THE PATIENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15636062 ↗
• MalfunctionAug 10, 2022Peeled/Delaminated; Device Damaged by Another Device; Material Deformation; Peeled/Delaminated; Device Damaged by Another Device; Material Deformation

  IT WAS REPORTED THAT, DURING SURGERY, METAL BURRS GRIND WITH LGN HOUSING RESECT COLLET S3-8 AND BINDS UP. DEVICE INSIDE THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15204281 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED THAT DURING TKA SURGERY THE LEGION HOUSING RESECT COLLET S3-8 BROKE INTO A COUPLE PIECES (OUTSIDE PATIENT). IT WAS USE A S&N BACK UP DEVICE. NO INJURY TO THE PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11798418 ↗
• MalfunctionJun 26, 2020Break; Break

  IT WAS REPORTED THAT DURING AN EFIP INSPECTION THE TIGHTENING SCREW WAS FOUND BROKEN.

  Patient problems: No Patient Involvement

  MAUDE report 10199765 ↗
• InjuryFeb 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, THE COLLET POPPED OFF WHILE HE WAS REAMING FOR THE BOX. THE DOCTOR ALMOST TOOK OFF HIS FINGER TODAY AS THE COLLET POPPED OFF WHILE HE WAS REAMING FOR THE BOX. THE SURGERY WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO DELAYS IN THE PROCEDURE AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: Injury

  MAUDE report 9734877 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY THE COLLECT POPPED OFF WHILE THE SURGEON WAS REAMING FOR THE BOX. SURGEON ALMOST TOOK OFF HIS FINGER. IT IS UNKNOWN IF THERE WAS A DELAY OR HOW THE PROCEDURE WAS CONCLUDED.

  Patient problems: Injury

  MAUDE report 9648114 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING SURGERY, SURGEON ALMOST TOOK HIS FINGER AS COLLET POPPED OFF WHILE HE WAS REAMING FOR THE BOX. IT IS UNKNOWN IF THERE WAS A DELAY OR HOW THE PROCEDURE WAS CONCLUDED.

  Patient problems: Injury

  MAUDE report 9647983 ↗
• MalfunctionApr 8, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, SCREW GOT JAMMED UP AND THEN JUST FELL APART. NOTHING GOT IN PATIENT. NO INJURY TO PATIENT. BACKUP DEVICE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8493823 ↗
• MalfunctionMar 28, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY IT WAS IDENTIFIED THAT THE BOX COLLET WAS BROKEN. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. IT IS UNKNOWN IF THERE WAS AFFECTATION TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8462278 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121393. One submission often covers many models, so check the product and lot details in each record.

• Z-0878-2020 · Dec 16, 2019 · Open, Classified
  LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 714344
• Z-0200-2019 · Sep 18, 2018 · Terminated
  Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to mak
• Z-2163-2018 · May 4, 2018 · Terminated
  smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
• Z-1902-2018 · Apr 9, 2018 · Terminated
  smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic a