LEGION 71441255Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556033661), received between Mar 26, 2022 and Jun 7, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY FOUR (4) LITTLE SCREWS ON FRONT OF GII SPC DCF SIZING GUIDE WERE LOOSE, THE LITTLE SCREWS FELL OFF AND INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT HAD TO COME BACK THE NEXT DAY TO GET SCREW REMOVED FROM BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19482843 ↗
• MalfunctionNov 1, 2023Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE GII SPC DCF SIZING GUIDE BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS A SURGICAL DELAYED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18050233 ↗
• MalfunctionSep 21, 2022Break; Break

  IT WAS REPORTED THAT A GII SPC DCF SIZING GUIDE IS BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461746 ↗
• MalfunctionSep 21, 2022Break; Break

  IT WAS REPORTED THAT A GII SPC DCF SIZING GUIDE IS BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460950 ↗
• MalfunctionMar 26, 2022Break; Break

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA SURGERY, THE HOLDING PIN CAM LOOSE AND FELL OUT OF THE GII SPC DCF SIZING GUIDE. ALL THE PIECES WERE RECOVERED. AS THIS WAS HAPPENED BEFORE THE PROCEDURE THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13925076 ↗

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