Reported Feb 11, 2015 · Terminated
KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use…
Medtronic Sofamor Danek USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Sofamor Danek USA Inc · 1800 Pyramid Place · Memphis, TN · 38132
Is this the product you have?
- KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A
- QTY1EA, Rx only, STERILE R. For use with spinal fixation devices
- Lot codes and dates
- WI14H054
- Amount recalled
- 239 units
Where it was sold
- Nationwide
Why it was recalled
The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.
This product could cause temporary or reversible health problems — stop using it.
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