GENESIS II 71433345Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556031926), received between Mar 3, 2021 and May 17, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2024Failure to Align; Failure to Align

  IT WAS REPORTED THAT, DURING TKA, AFTER PERFORMING FEMORAL CUTS WITH THE GII MIS DCF AP CUTTING BLOCK 5, THE GII SPC REAMTHRU CR TRIAL-SIZE 5 LEFT DID NOT MATCH THE CHAMFER CUTS PREVIOUSLY RESECTED. DUE TO THIS, THE SURGEON MANUALLY PERFORMED AGAIN THE CHAMFER CUTS, WHICH ALLOWED THE SIZE 5 IMPLANT TO FIT WELL, BUT STILL WERE NOT ALIGNING WITH THE SIZE 5 FEMORAL TRIAL. SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, BY PLACING THE INITIALLY PLANNED SIZE 5 IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19344948 ↗
• MalfunctionAug 18, 2021Crack; Crack

  IT WAS REPORTED THAT A GII SPC REAMTHRU CR TR SZ 5 LT HAS A CRACK ON THE TRIAL. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340245 ↗
• MalfunctionJul 22, 2021Crack; Crack

  IT WAS REPORTED THAT, A GENESIS II SPC REAMTHRU CR TR SIZE 5 LEFT WAS FOUND WITH A CRACK. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211848 ↗
• MalfunctionMar 3, 2021Break; Break

  IT WAS REPORTED THAT THE GII SPC REAMTHRU CR TR SZ 5 LT IS BROKEN. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11402942 ↗

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