Device Recall SIGMA

  • Model / Serial
    Lots X78C54, X78C64 and X78C74.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.
  • Product Description
    Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz 2, 15.0 mm; Ref 96-2323.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Depuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Source
    USFDA

40 devices with a similar name

Learn more about the data here

  • Model / Serial
    All lots
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and the District of Columbia., and to the countries of : Australia, Austria, Belgium, Canada, Croatia, Denmark, Finland, France, Germany, India, Ireland, Italy, Korea, Luxembourg, Malaysia, Netherlands, Portugal, Singapore, Slovakia. Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom.
  • Product Description
    (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645; (5) Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500, GTIN: 10603295001652; (6) Sigma HP Cemented Trochlea Size 1 Narrow Right, Catalog Number: 102404100, GTIN: 10603295001669; (7) Sigma HP Cemented Trochlea Size 2 Narrow Right, Catalog Number: 102404200, GTIN: 10603295001676; (8) Sigma HP Cemented Trochlea Size 3 Narrow Right, Catalog Number: 102404300, GTIN: 10603295001683; (9) Sigma HP Cemented Trochlea Size 4 Narrow Right, Catalog Number: 102404400, GTIN: 10603295001690; (10) Sigma HP Cemented Trochlea Size 5 Narrow Right, Catalog Number: 102404500, GTIN: 10603295001706
  • Manufacturer
  • Model / Serial
    Lot Y88D14.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.
  • Product Description
    Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 2.5, 8 mm; Ref 97-0340.
  • Manufacturer
  • Model / Serial
    Lot Y88D64.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.
  • Product Description
    Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 97-0352.
  • Manufacturer
  • Model / Serial
    Lots X23AD4 and X23AE4.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.
  • Product Description
    Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 15.0 mm; Ref 97-0353.
  • Manufacturer
  • Model / Serial
    Lot Y88D94.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.
  • Product Description
    Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 97-0361.
  • Manufacturer
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