Recall Z-2247-2017— Medtronic Sofamor Danek USA Inc
Class II · Terminated
Class II FDA medical device recall by Medtronic Sofamor Danek USA Inc, initiated 2017-05-17, terminated 2019-06-18. FDA's recall record names no specific 510(k) clearance for this event. Product: KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.. Reason: 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..
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-05-17
- Terminated
- 2019-06-18
- Firm location
- Memphis, TN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.