FDAJanuary 8, 2016device

SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin. Surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space. Insert Dislocation or Spin Out, or Poor Joint Mechanics may result, if not noted during surgery. May require revision surgery.

What to do

FDA enforcement status: Terminated

Brands named

depuy orthopaedicsdepuy

UPCs

1060329522736610603295227373106032952273801060329522740310603295227410

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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