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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
Related recalls
Same manufacturer · Medtronic Sofamor Danek USA Inc
See all →- HighExpandable spinal cages recalled because they may lose height or collapse
FDA (Devices) · 2025-12-03
- HighGrafton Plus DBM Paste medical device recalled for packaging inspection failure
FDA (Devices) · 2023-11-01
- HighGrafton DBM Demineralized Bone Matrix Recall Due to Sterile Packaging Inspection Failure
FDA (Devices) · 2023-11-01
- ModerateGrafton DMB Matrix bone graft recalled for potential outer pouch defects
FDA (Devices) · 2023-11-01
- HighGrafton DBM Orthoblend Recall Due to Sterile Packaging Inspection Issue
FDA (Devices) · 2023-11-01
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighMedtronic KYPHON Express Directional Bone Filler Device Recall
FDA (Devices) · 2018-01-24
- HighMedtronic Recalls KYPHON Directional Bone Filler Devices Due to Alignment Defect
FDA (Devices) · 2017-06-14
- HighMedtronic spinal implant recall due to out-of-specification device dimensions
FDA (Devices) · 2023-07-19
- HighMedtronic Catalyft LS spinal implant recalled for out-of-specification device dimensions
FDA (Devices) · 2023-07-19
- HighMedtronic Premier Anterior Cervical Plate Screw Block Recall
FDA (Devices) · 2012-10-17
- ModerateMedtronic Endoskeleton TC Interbody System Recalled for Incorrect Size Labeling
FDA (Devices) · 2021-04-28