KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Reported: June 14, 2017 Initiated: May 17, 2017 #Z-2247-2017
Product Description
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Reason for Recall
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.
Details
- Recalling Firm
- Medtronic Sofamor Danek USA Inc
- Units Affected
- 17657 units
- Distribution
- worldwide
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.. Recalled by Medtronic Sofamor Danek USA Inc. Units affected: 17657 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2017. Severity: Moderate. Recall number: Z-2247-2017.
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