Device Recall Stryker

  • Model / Serial
    Part Number: 234-010-078, Lot # 32101;  Part Number: 234-010-080, Lot # 32103
  • Product Classification
  • 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
  • 1 Event

Manufacturer

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

499 devices with a similar name

Learn more about the data here

  • Model / Serial
    Catalog #6260-9-236 - Head Diameter 36 mm, Offset +5, including all lots manufactured from 1/102 - 7/1/10; Catalog #6260-9-240 - Head Diameter 40 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-244 - Head Diameter 44 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-340 - Head Diameter 40 mm, Offset +8, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-440 - Head Diameter 40 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-344 - Head Diameter 44 mm, Offset +8, including all lots manufactured from 1/1/07 - 3/4/11 and Catalog #6260-9-444 - Head Diameter 44 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide and Internationally
  • Product Description
    LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.
  • Manufacturer
  • Model / Serial
    Catalog #5901-1038
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Reunion TSA Peg Alignment Sound || Catalog #5901-1038 || The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA Self-Pressurizing Polyethylene Glenoid implant prior to final implantation into the glenoid vault. Its purpose is to provide assurance that the drilled holes for seating of the Glenoid implant have been properly prepared using the provided instrumentation
  • Manufacturer
  • Model / Serial
    Lot #202085 Stryker Product Number: 6001-420-000
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) Distribution to the states of : CA, CT, GA, IL, IN, MA, MD, NC, OH, PA, TN, and TX.
  • Product Description
    Stryker PROFESS Registration Kit. || The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraoperative guidance system to enable intranasal and sinus computer-assisted surgery. The system is comprised of PROFESS Registration Stickers, a PROFESS Patient Tracker, and a PROFESS Adaptor Cable.
  • Manufacturer
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