Device Recall Triathlon

  • Model / Serial
    Ref. No. 5530-G-211 Lot code G9XF6  LAF974
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Canada.
  • Product Description
    Triathlon X3 CR Tibial Bearing Insert || for knee prosthesis || Size #2 - 11MM || Ref # 5530-G-211 || 2011-09 || Howmedica Osteonics Corp.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

36 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers: 36325001; 36325102;36325302; 36325402; 36325602; 36326002; 36326201;33936308; 36605501; 36326601; 33934303; 33934705; 36327201; 36327301; 36327401; 36328101; 35453302; 36378501; 36604001; 36379001; 36379101; 36379201; 36379301; 36379401; 36604301; 36379501; 36604502; 36379901; 36326301; 36380001; 36380101; 35728201; 36380401; 36380601; 36380901; 36381201; 36381401; 35730101; 36381601; 35730602; 35921201; 35921301; 36382001; 35730801; 35730802; 35730803 and 36382101.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States and Canada.
  • Product Description
    Triathlon X3 UHMWPE Tibial Inserts and Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ. || Intended to be used with femoral components in primary or revision total knee arthroplasty.
  • Manufacturer
  • Model / Serial
    5560-S-209, TRI CEMENTED STEM 9MMX100MM, Lot N3N31K and 5560-S-209, TRI CEMENTED STEM 9MMX100MM, Lot N3N31W
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
  • Product Description
    Triathlon Cemented Stem - Knee || These devices are modular components of a total knee system. These modular stems are intended for use with femoral and tibial components in primary or revision total knee arthroplasty.
  • Manufacturer
  • Model / Serial
    8 mm - LM/RL Catalog number 5630-G-108, Lot code NXDMEE; 12 mm -RM/LL Catalog number 5630-G-122 Lot code M8JMEE.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: Product was distributed to 7 Stryker branches and one hospital.
  • Product Description
    Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE || Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE || Intended Use: || - Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis || - Revision of previous unsuccessful surgical procedures, either involving, or || not involving, previous use of a unicompartmental knee prosthesis || - As an alternative to tibial osteotomy in patients with unicompartmental || osteoarthritis, where bone stock is of poor quality or inadequate for other || reconstructive techniques as indicted by deficiencies of the femoral || condyle/tibia plateau. || These components are intended for implantation with bone cement. || Stryker Orthopaedics; || Howmedica Osteonics Copr. || 325 Corporate Drive || Mahwah, NJ 07430
  • Manufacturer
  • Model / Serial
    Lot code LBD528 and Lot code LBD512.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution: FL and IL.
  • Product Description
    Triathlon X3 Posterior Stabilized Tibial Insert || Use with Triathlon PS Femoral Components. || Sze 7, THKNS 13 m and SZE 8, THKNS 13mm; || Catalog number 5532-G-713, Catalog number 5532-G-813 || Stryker Orthopaedics
  • Manufacturer
  • Model / Serial
    Catalog no. 6541-0-701, 6541-0-702, 6541-0-703, 6541-0-704, 6541-0-705, 6541-0-706, 6541-0-707, 7541-0-708. All lot codes.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Triathlon AR 4:1 Cutting Blocks - Size 1-8; || Catalog Numbers: 6541-0-701, 6541-0-702, 6541-0-703, 6541-0-704, 6541-0-705, 6541-0-706, 6541-0-707, & 6541-0-708; || Triathlon MIS Instruments; || Non Sterile || Stryker Orthopaedics || 325 Corporate Drive || Mahwah, NJ 07430 || The Triathlon AR 4:1 Cutting Blocks and the Triathlon MIS 4:1 Cutting Blocks are used to prepare the Femur (bone cuts) for the Triathlon femoral component.
  • Manufacturer
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