Medtronic Recalls KYPHON Directional Bone Filler Devices Due to Alignment Defect
Medtronic is recalling KYPHON Directional Bone Filler Devices because the directional arrow may not align with the opening, potentially causing cement to be placed in an unintended direction.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that could lead to unintended placement of surgical cement, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 17,657 units of the KYPHON(R) Directional Bone Filler Device, Size 3, REF F04C. The recall covers all lots and the devices were distributed worldwide.
The recall is due to a defect where the directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end. This misalignment may result in the injected cement being placed in a direction unintended by the surgeon.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 17,657
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distribution scope not specified by the agency.
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