PROFIX 71512449Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010223869), received between Mar 18, 2024 and Apr 1, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Fell” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Device Fell

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) PRO BONE SPIKE-SHORT FELL INTO THE FEMORAL CANAL DURING A SURGICAL PROCEDURE WHILE REMOVING THE PIN THAT FIXES THE TRIAL TIBIAL PLATE, AND THE DEVICE COULD NOT BE EXTRACTED. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED; OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24750701 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TKA REVISION SURGERY, WHEN REMOVING THE PRO BONE SPIKE-SHORT FROM THE TIBIA MEASUREMENT, IT FELL INTO THE BONE CAVITY AND WAS NOT POSSIBLE TO REMOVE. SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS NOT HARMED DUE TO THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 18927188 ↗

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