Medtronic Recalls KYPHON EXPRESS Osteo Introducer System Due to Labeling Error
Medtronic is recalling 239 units of the KYPHON EXPRESS Osteo Introducer System because the packaging may contain the wrong instrument tips.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a labeling error regarding instrument tips without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 239 units of the KYPHON EXPRESS Osteo Introducer System, Diamond and Bevel, Size 2 (REF T34A). The product is a sterile, prescription-only medical device intended for use with spinal fixation devices.
The recall was initiated because the product is labeled as containing one bevel-tipped instrument and one diamond-tipped instrument, but the actual contents may consist of either two bevel-tipped instruments or two diamond-tipped instruments. This discrepancy represents a labeling error regarding the specific components included in the package.
The affected units were distributed nationwide in the United States and in Canada. The specific lot code for the recalled product is WI14H054. Healthcare providers and facilities should stop using the affected units and contact Medtronic for further instructions on how to return or dispose of the product.
The recalled product
- Product
- KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA, Rx only, STERILE R. For use with spinal fixation devices.
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Category
- Medical Device — Spinal Fixation
- Hazard
- Affected units
- 239
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)
- WI14H054
Distribution
Distributed nationwide across the United States.
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