Medtronic KYPHON Express Directional Bone Filler Device Recall
Medtronic is recalling KYPHON Express Directional Bone Filler Devices because the directional arrow may not align with the opening.
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 3/5 (High).
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 impact the safety or effectiveness of a procedure, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 3,319 units of the KYPHON(R) Express(TM) Directional Bone Filler Device, Size 2. The recall affects specific lot numbers including WI424428, WI428822, and WI435227, among others. The devices were distributed in the United States and several international locations, including Austria, Belgium, Canada, and Germany.
The recall was initiated because Medtronic discovered that the directional arrow at the proximal end of the instrument may not correctly align with the cut-out opening on the distal end of the instrument. This misalignment could affect the intended function of the device during use.
Healthcare providers and facilities should stop using the affected devices and contact Medtronic for further instructions. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- Affected units
- 3,319
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 (15)
- UDI 00643169097254 Lot Numbers: WI424428
- WI428822
- WI435227
- WI439940
- WI442555
- WI446722
- WI449819
- WI455595
- WI459477
- WI463434
- WI472175
- WI472178
- WI472176
- WI472177
- WI474575
Distribution
Distribution scope not specified by the agency.
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