Reported Jun 14, 2017 · Terminated
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
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 Pl · Memphis, TN · 38132-1703
Is this the product you have?
- KYPHON(R) Directional Bone Filler Device
- Size3, REF F04C, Rx Only, STERILE R
- Lot codes and dates
- All Lots
- Amount recalled
- 17657 units
Why it was recalled
The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected bone void filler may result in the injected cement being placed in a direction unintended by the surgeon.
This product could cause temporary or reversible health problems — stop using it.
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