Synthes USA, Ti Synex II Vertebral Body Replacement

Recall Class: Class I
Date Recall

Initiated:

September 14, 2009
Product:

Ti Synex II Vertebral Body Replacement (VBR)

 

This recall involves part numbers 04.808.001-11, Synex II Central Body, Titanium (all lots).

 

Part Numbers Descriptions

04.808.001

04.808.002

04.808.003

04.808.004

04.808.005

04.808.006

04.808.007

04.808.008

04.808.009

04.808.010

04.808.011

 

Ti Synex (TM) II Central Body 14 mm – 19 mm

Ti Synex (TM) II Central Body 17 mm – 25 mm

Ti Synex (TM) II Central Body 21 mm – 29 mm

Ti Synex (TM) II Central Body 25 mm – 33 mm

Ti Synex (TM) II Central Body 29 mm – 44 mm

Ti Synex (TM) II Central Body 37 mm – 52 mm

Ti Synex (TM) II Central Body 45 mm – 71 mm

Ti Synex (TM) II Central Body 58 mm – 84 mm

Ti Synex (TM) II Central Body 71 mm – 97 mm

Ti Synex (TM) II Central Body 84 mm -110 mm

Ti Synex (TM) II Central Body 97 mm -123 mm

 

This product was manufactured from June 8, 2007 through September 9, 2009 and distributed from July 2, 2007 through September 8, 2009.

Use: This device is a vertebral body replacement device that is used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body due to a tumor or trauma (that is, a fracture).
Recalling Firm: Synthes USA
1302 Wrights Lane East
West Chester, Pennsylvania  19380-3417
Reason for Recall: Loss of device height may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for a reoperation or an operation to modify the implanted device.
Public Contact:

Physicians who have:

  • questions may contact the company at 1-800-620-7025 extension 5375, 8:30 a.m. – 4:30 p.m., Monday through Friday, Eastern Time.
  • patients who experienced adverse reactions/events with this device should report to Synthes at:
    • Phone: 1-800-752-0128, 8:30 a.m.- 4:30 p.m., Monday through Friday, Eastern Time, or
    • Email:  ComplaintUnit@synthes.com

 

Patients who have this recalled device and have increased pain, other symptoms, or questions should contact their surgeon.

For more information, see Useful Links below.

 

FDA District: Philadelphia
FDA Comments:

Hospitals and surgeons that have these recalled devices must stop implanting them immediately.

On September 23, 2009, the company notified hospitals and sales consultants about this recall by mail.  The company:

  • identified the recalled product
  • described the problem and potential health effects
  • provided instructions to their customers to return all products in their inventory and all surgically removed devices for evaluation.
  • notified and provided instructions to physicians and patients (through their physicians)

On November 09, 2009, the company sent physicians a follow up letter for their patients.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause adverse health consequences or death.

There are 2 comments. Add yours.

  1. Emily Neumann

    I have this device and was notified of the recall. I am a year out of surgury and still have bad pain. I was told by my doctors NOT under any circumstances to contact my surgeon. No matter what my questions cant be answered because no one knows the answers. Its kind of hard when you feel all alone.

    Reply
  2. JUDITH L ROTONDO

    How do you truly know if your physician at that time of surgery used the recalled items or not?

    Reply

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