BEUDAMED
    FDA Recall Terminated

    Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe.

    Recall: Z-1866-2012 · Initiated May 21, 2012

    Recall

    Recall Number
    Z-1866-2012
    Event Number
    61955
    Firm
    Stryker Endoscopy
    FEI Number
    2936485
    Product Code
    GFA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 21, 2012
    Posted
    June 25, 2012
    Terminated
    September 20, 2012
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400

    Description

    Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe.

    Reason

    Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific serial numbers of Formula and 180 Shaver Hand Control.

    Action

    The firm, Stryker Endoscopy, sent an "Urgent: Device Removal" letter dated May 21, 2012 to all affected customers via Federal Express. Stryker Sales Reps were notified by e-mail on the same day. Stryker international sites were notified by e-mail on May 24, 2012. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their inventory for part and serial number; quarantine any of the affected product, call Stryker Endoscopy's Customer Service at 1-800-624-4422 for replacements and return affected product. If you have any questions regarding this letter please contact us at [email protected] or call 1-800-624-4422.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: CA, FL, IA , MI, NV, NC, OK, TX, and WI; and countries of: China and Great Britain.

    Quantity

    34 devices