SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.
Check against the official notice below — it lists the full affected range.
DePuy Orthopaedics, Inc. is recalling 351 units of the SIGMA HP MBT Non-Keel Punch Knee Instrument worldwide. The instrument has an increased punch height that creates a 0.063 inch (1.6 mm) gap between the trial and the instrument. This gap may cause surgeons to select an insert that is too thin, and if the punch dislodges from the inserter during surgery, it may become lodged in the joint space, causing surgical delays. If not identified during the procedure, the undersized insert could result in insert dislocation, spin out, or poor joint mechanics, potentially requiring revision surgery.
The recalled devices were distributed worldwide to locations including the United States and numerous countries across Europe, Asia, Africa, and South America. Affected lot numbers include specific catalog numbers for both cemented and noncemented punch sizes ranging from 1 to 7. The source document does not specify a remedy for consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: 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 Africa, Spain, Sweden, South Korea, Switzerland, Thailand, Turkey, UAE, UK, and Brazil. Quantity: 351 Lot/code info: Cat. No. GTIN Lot Description 950502016 10603295227366 ABB92402 SIGMA HP MBT Cemented Punch size 1-1.5 950502017 10603295227373 ABB84491 SIGMA HP MBT Cemented Punch size SZ 2-3 950502018 10603295227380 ABB92358 SIGMA HP MBT Cemented Punch size SZ 4-7 950502020 10603295227403 ABC33125 SIGMA HP MBT Noncemented Punch size 2-3 950502020 10603295227403 ABB81733 SIGMA HP MBT Noncemented Punch size SZ 2-3 950502020 10603295227403 ABB81732 SIGMA HP MBT Noncemented Punch size SZ 2-3 950502021 10603295227410 ABB39952 SIGMA HP MBT Noncemented Punch size SZ 4-7 950502021 10603295227410 ABC33123 SIGMA HP MBT Noncemented Punch size SZ 4-7
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.