Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all implants and instruments required f
FDA device recall Z-1475-2011 · posted 2011-03-02 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- The IFU provided with the device contains incorrect information in the Indications for Use Section, stating the following: The Theken Spine Vu a"POD Intervertebral Body Fusion Device is intended for use as a stand alone implant when used with the SpinPlate provided in the set.
- Action taken
- On 10/19/2010 the firm sent "URGENT : FIELD CORRECTION ACTION Letters to their customers. The letters identified the affected product and explained the reason for the recall. The letter also stated that the issue is not believed to have a health impact on patients. Physicians are asked to continue to exercise their clinical judgment with any periodic patient follow up. Attached to the letters were IFUs containing the correct information. Customers are to complete and return the enclosed Recall Acknowledgement Form per the instructions provided. Questions can be directed to Suzanne B. Wojcik, Sr. Dir Regulatory Affairs and Quality Assurance, at 330-835-8528.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MQP
- Quantity affected
- 2,163 pieces
- Distribution
- Nationwide Distribution -- AL, AZ, CA, CT, ID, KS, MO, NH, NV, NY, OH, OK, TX & UT.
- Date initiated
- 2010-10-19
- Date posted
- 2011-03-02
- Date terminated
- 2012-09-19
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VU APOD INTERVERTABRAL BODY FUSION DEVICE (K080822) | Theken Spine, LLC | 2008-07-02 |