Events

Recall of Device Recall BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Orthofix, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53968
  • Event Risk Class
    Class 2
  • Event Number
    Z-0641-2010
  • Event Initiated Date
    2009-11-19
  • Event Date Posted
    2010-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86980
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Intervertebral fusion device with bone graft, lumbar - Product Code MQP
  • 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.

Device

Device Recall BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
  • Model / Serial
    Part number: 49-1100, Lot Number 17301-L125.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    United States (IA, NV, CO, AZ, NY, MD, IL, VA, MN, MI, NC, CT, LA, AR, GA, CA, MO, WA, OK and AL).
  • Product 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.
  • Manufacturer
    Orthofix, Inc

Manufacturer

Orthofix, Inc
  • Manufacturer Address
    Orthofix, Inc, 1720 Bray Central Dr, McKinney TX 75069-8207
  • Manufacturer Parent Company (2017)
    Orthofix International Nv
  • Source
    USFDA