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Devices
Device Recall DePuy Sigma LCS
Model / Serial
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
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
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.
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.
Manufacturer
DePuy Orthopaedics, Inc.
1 Event
Recall of Device Recall DePuy Sigma LCS
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Manufacturer
DePuy Orthopaedics, Inc.
Manufacturer Address
DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
USFDA
Language
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