BEUDAMED
    FDA Recall Terminated

    Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. Case contents: Implant Insertion Instrument, Straight Tamp, Bone Awl Drill Guide, Straight Drill, U-Joint Driver with and without retention, Flex Shaft Driver, Trial Insertion Instrument, Drill Tips, Cover Plate Inserter, Cover Plate Driver, Cover Plate Holder, Ratcheting Handle, Torque Limiting Handle, Hex Driver, Distractors/Sizers, Sizers REF: 49-0021: Orthoflex Spinal Implants, 1211 Hamburg Tnpk, Suite 300, Wayne, NJ 07470. The Pillar SA Implant Insertion Instrument is intended for intraoperative use in placing/inserting Pillar SA implants into a prepared interbody space.

    Recall: Z-0641-2010 · Initiated November 19, 2009

    Recall

    Recall Number
    Z-0641-2010
    Event Number
    53968
    Firm
    Orthofix, Inc
    FEI Number
    2183449
    Product Code
    MQP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 19, 2009
    Posted
    January 15, 2010
    Terminated
    February 2, 2010
    Address
    1720 Bray Central Dr, McKinney, TX, 75069-8207

    Description

    Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. Case contents: Implant Insertion Instrument, Straight Tamp, Bone Awl Drill Guide, Straight Drill, U-Joint Driver with and without retention, Flex Shaft Driver, Trial Insertion Instrument, Drill Tips, Cover Plate Inserter, Cover Plate Driver, Cover Plate Holder, Ratcheting Handle, Torque Limiting Handle, Hex Driver, Distractors/Sizers, Sizers REF: 49-0021: Orthoflex Spinal Implants, 1211 Hamburg Tnpk, Suite 300, Wayne, NJ 07470. The Pillar SA Implant Insertion Instrument is intended for intraoperative use in placing/inserting Pillar SA implants into a prepared interbody space.

    Reason

    The Pillar SA Implant Insertion Instrument 49-1100 may experience resistance in turning the activation knob while releasing an implant after intra-operative positioning.

    Action

    A notification letter dated November 19, 2009 was sent to customers via Federal Express. The letter described the recalled product (PILLAR SA Implant Insertion Instrument, 49-1100) and problem and actions for customers to take. The affected product, PILLAR SA lmplant lnsertion lnstrument, 49-1100 is in the PILLAR SA set (set part number 49-0021) which was shipped to customers. An enclosed attachment provide instructions on product removal and return. Customers were instructed to complete the enclosed Tracking and Verification Form and fax to Orthofix Spinal Implants at 1-973-406-2912. A replacement instrument will be provided as available. In the interim, the Implant Inserter (Part Number 49-1000) included in the PILLAR SA UPE set (set number 49-0020) that was provided earlier this year may be used as an alternative to the affected product. For questions regarding the removal and return of the recalled product to Orthofix Spinal Implants, please contact your Account Services Representative. Direct other questions to the Regulatory Affairs Department at 1-973-406-2812. Direct product questions to Marketing at 1-862-221-1335 or Product Development at 1-973-406-2824.

    Distribution

    United States (IA, NV, CO, AZ, NY, MD, IL, VA, MN, MI, NC, CT, LA, AR, GA, CA, MO, WA, OK and AL).

    Quantity

    29 instruments