Devices

Device Recall Stryker

  • Model / Serial
    Part Number: 234-010-078, Lot # 32101;  Part Number: 234-010-080, Lot # 32103
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    6 consignees (locations to be determined) received 15 units. the remaining 147 units were distributed to international divisions.
  • Product Description
    Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm || Part Numbers: 234-010-078; 234-010-080
  • Manufacturer
    Stryker Endoscopy
  • 1 Event

Manufacturer

Stryker Endoscopy
  • Manufacturer Address
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA

499 devices with a similar name

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Device Recall STRYKER CASSETTE PUMP, AHTO Tube Set
  • Model / Serial
    a. Model 0250070600, UDI 07613327061499, Lot No. 17284FG2, 17291FG2, 17300FG2;  b. Model 0250070620, UDI 07613327061659, Lot No. 17275FG2, 17279FG2, 17280FG2, 17282FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17291FG2, 17292FG2, 17293FG2, 17297FG2, 17298FG2, 17299FG2;
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed domestically to . Distributed internationally to Australia and Mexico.
  • Product Description
    STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: || a. Stryker AHTO Tube Set Packaging (Model 0250070600); || b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);
  • Manufacturer
    Stryker Corporation
Device Recall STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw
  • Model / Serial
    Model 0234010056, UDI 04546540754561, Lot No. 17278AG2
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed domestically to . Distributed internationally to Australia and Mexico.
  • Product Description
    STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.
  • Manufacturer
    Stryker Corporation
Device Recall Stryker InterPulse Irrigation System
  • Model / Serial
    1. Lot Numbers: 17283012, 17284012, 17286012; 2. Lot Numbers: 17278012, 17280012, 17282012, 17283012, 17285012, 17289012, 17292012; 3. Lot Number: 17279012; 4. Lot Number: 17284012   UDI: (01)4546540861641; (01)4546540861764; (01)4546540861818; (01)4546540144300
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
  • Product Description
    1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 || for orthopedic use.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
Device Recall Stryker VertePort Cement Cannulas and Access Cannulas
  • Model / Serial
    Lot Number: 17278012  UDI: (01)7613252594307
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
  • Product Description
    11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 || for spinal orthopedic use.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
Device Recall Stryker AutoPlex System
  • Model / Serial
    1. Lot Number: 17278012; 2. Lot Numbers: 17278012, 17278022, 17279022, 17282012, 17282022, 17291012, 17291022   UDI: (01)4546540593108; (01)7613252039259
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
  • Product Description
    1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 || Bone cement.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation
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