Recalls / —
—#163451
Product
Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body
- FDA product code
- KWQ — Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K141632
- Affected lot / code info
- GTIN/UPN: 643169329218 Lot Number: H5399679
Why it was recalled
Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.
Root cause (FDA determination)
Process control
Action the firm took
The firm initiated their recall by letter on 03/23/2018. The recall notice requested: "1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via email to rs.sdmriskmgt@medtronic.com. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product. "
Recalling firm
- Firm
- Medtronic Sofamor Danek USA Inc
- Address
- 1800 Pyramid Pl, Memphis, Tennessee 38132-1703
Distribution
- Distribution pattern
- Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France
Timeline
- Recall initiated
- 2018-03-23
- Terminated
- 2021-07-25
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #163451. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.