Home / Recalls / DePuy Orthopaedics, Inc. / Z-0787-2016

Z-0787-2016 Class II Terminated

Recalled by DePuy Orthopaedics, Inc. — Warsaw, IN

FDA device recall Z-0787-2016 was initiated by DePuy Orthopaedics, Inc. on Jan 8, 2016 and is designated Class II. 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… The recall status is terminated (terminated Mar 24, 2017). Affected quantity: 351.

Recall Details

Product Type: Devices
Report Date: Feb 17, 2016
Initiation Date: Jan 8, 2016
Termination Date: Mar 24, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 351

Product Description

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

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 Pattern

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.

Code Information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0787-2016
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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