Reported Feb 17, 2016 · Terminated
SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during…
DePuy Orthopaedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Barcodes Product as published 95050201610603295227366ABB92402 SIGMA HP MBT Cemented Punch size 1-1.5 95050201710603295227373ABB84491 SIGMA HP MBT Cemented Punch size SZ 2-3 95050201810603295227380ABB92358 SIGMA HP MBT Cemented Punch size SZ 4-7 95050202010603295227403ABC33125 SIGMA HP MBT Noncemented Punch size 2-3 95050202010603295227403ABB81733 SIGMA HP MBT Noncemented Punch size SZ 2-3 95050202010603295227403ABB81732 SIGMA HP MBT Noncemented Punch size SZ 2-3 95050202110603295227410ABB39952 SIGMA HP MBT Noncemented Punch size SZ 4-7 95050202110603295227410ABC33123 SIGMA HP MBT Noncemented Punch size SZ 4-7 - Amount recalled
- 351
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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