BEUDAMED
    FDA Recall Terminated

    Interventional Pain 6" 15 G (1.85 mm) Percutaneous Discectomy Probe, REF 407-266, Sterile, Stryker Instruments, Kalamazoo, MI. The DeKompressor Percutaneous Discectomy Probe is intended for use in the apiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine

    Recall: Z-1830-2011 · Initiated February 3, 2011

    Recall

    Recall Number
    Z-1830-2011
    Event Number
    57899
    Firm
    Stryker Instruments Division of Stryker Corporation
    FEI Number
    1811755
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 3, 2011
    Posted
    March 28, 2011
    Terminated
    June 1, 2011
    Address
    4100 East Milham Ave., Kalamazoo, MI, 49001

    Description

    Interventional Pain 6" 15 G (1.85 mm) Percutaneous Discectomy Probe, REF 407-266, Sterile, Stryker Instruments, Kalamazoo, MI. The DeKompressor Percutaneous Discectomy Probe is intended for use in the apiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine

    Reason

    The firm received five complaints that the stylet did not fit down the cannula. The investigation revealed that the incorrect probe assembly was packaged for two DeKompressor part numbers with the lot number of 10214012.

    Action

    Stryker Instruments Division of Stryker Corporation sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated February 3, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their inventory for any recalled product and quarantine any affected product. If the product was further distributed, customers were asked to forward the letter and the completed Reply Form to all affected locations. Customers were to be contacted to coordinate return of the affected product. Upon receipt of the product, a replacement would be issued to their account. For questions regarding this recall call 1-800-253-3210.

    Distribution

    Worldwide Distribution - USA including the states of PA, NY, KS, NJ, TX, MI, OK, and FL, and the countries of Italy and Switzerland.

    Quantity

    44 units both products