DePuy Orthopaedics, Inc. recalls SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during tr…

Recall date

January 8, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0787-2016

FDA classification

Class II

Brand / firm

DePuy Orthopaedics, Inc.

Sold / distributed

Worldwide Distribution-US Nationwide, Armenia, Australia, Austria, Belgium, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, P R China, Portugal, Poland, Russia, Singapore, Slovenia, South…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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