Medtronic recalls specific size 2 directional bone filler devices due to potential misalignment of the directional arrow, which could lead to improper surgical placement. Affected units have unique lot numbers and are prescription-only.
Medtronic has discovered 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.
Medtronic is recalling certain size 2 directional bone filler devices because the directional arrow might not align correctly with the cutout on the device. This could cause improper surgical placement during procedures, which may affect the outcome of the surgery.
The directional arrow at the proximal end of the device may not align properly with the cutout opening at the distal end. This misalignment could lead to improper surgical placement during procedures, potentially affecting the outcome of spinal surgery.
Prescription-only medical devices for spinal surgery. Patients who received this specific device model with the listed lot numbers are most at risk.
Check for the product name 'Medtronic KYPHON Express Directional Bone Filler Device, SIZE 2, REF FB'. Look for lot numbers: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472178, WI472176, WI472177, WI474575.
Look for the lot numbers listed in the recall: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472178, WI472176, WI472177, WI474575.
The recall states the directional arrow may not align correctly with the cutout, which could lead to improper surgical placement. However, the remedy is not specified, so the device is not being recalled for immediate safety risks.
Check for the product name 'Medtronic KYPHON Express Directional Bone Filler Device, SIZE 2, REF FB' and the specific lot numbers listed in the recall.
The recall does not specify a remedy, so no action is required. However, you should check the lot number to confirm if your device is affected.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0352-2018 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0352-2018 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
