NA 71933037Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010592071), received between May 21, 2019 and Oct 18, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2022Break; Break

  IT WAS REPORTED THAT THE TOP OF THE KNEE BALANCER SHAFT BROKE OFF, THUS THE INSTRUMENTATION PADDLE ROTATES FREELY ON IT. AS THIS WAS NOTICED DURING FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15626404 ↗
• MalfunctionFeb 18, 2020Break; Break

  IT WAS REPORTED THAT THE SURGEON COMPLAINED THAT MEASUREMENT MARKERS HAVE BECOME DIFFICULT TO SEE. NO PATIENT INJURY, SURGERY COMPLETED WITH THE SAME ITEM, NO CLOSURE LETTER NEEDED, NO PICTURES AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9720102 ↗
• MalfunctionMay 21, 2019Defective Component; Defective Component

  IT WAS REPORTED THAT DURING A TKA PROCEDURE, THE CONNECTING ROD OF THE GAP BALANCER CAN BE CONNECTED TO EITHER THE STRAIGHT GAP BLOCK OR THE CONNECTED BUCKLING BLOCK, BUT THE FAULT TOOL LINK CANNOT CONVERT THE TWO BLOCKS. UNABLE TO PULL OUT. DELAY OF MORE THAN 2 HOURS REPORTED. NO CONFIRMATION OF BACKUP HAS BEEN RECEIVED. NO IMPACT OR INJURY TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8626413 ↗

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