Lower risk Medical device recall · FDA · Published December 6, 2017

Medtronic KYPHON Express Bone Filler Device Recall: Directional Alignment Risk

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0352-2018Medical device Medtronic ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmMedtronic Sofamor Danek USA Inc1800 Pyramid Pl · Memphis, TN 38132-1703

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/72391-medtronic-kyphon-express-bone-filler-device-recall-directional-alignment-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/72391-medtronic-kyphon-express-bone-filler-device-recall-directional-alignment-risk · Updated August 31, 2026 · FDA enforcement record: FDA #Z-0352-2018

Cite this page

“Medtronic KYPHON Express Bone Filler Device Recall: Directional Alignment Risk.” GovInfoNow, updated August 31, 2026. https://govinfonow.com/recall/72391-medtronic-kyphon-express-bone-filler-device-recall-directional-alignment-risk. Based on FDA recall #Z-0352-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0352-2018%22&limit=1).

Medtronic Sofamor Danek USA Inc recalled Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB on Dec. 6, 2017, according to the FDA. The hazard is that the directional arrow at the proximal end may not correctly align with the cut out opening on the distal end of the instrument.

How to tell if you have it

Brand: Medtronic
Product: Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB
Lot Numbers: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472178, WI472176, WI472177, WI474575
Units affected: 3,319

The hazard

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.

Context

GovInfoNow's records show Medtronic Sofamor Danek USA Inc has 19 other recalls on record since 2017-12-22. Other recent recalls include a Medtronic 6069073 recall (2025-09-16) and a Medtronic Sofamor Danek Grafton Plus DBM Paste Recall (2023-09-26). Similar product recalls include U2 Total Knee System Femoral Offset Bushing Recall (2026-03-19), TMJ Bilateral Implants Recall (2026-02-11), and Medartis APTUS Screws recall (2026-04-24).

How to tell if you have this one

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.

Brand
Medtronic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Look for the lot numbers listed in the recall: WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472178, WI472176, WI472177, WI474575.

How this recall unfolded

Recall timeline

FDA terminated this recall 23 months after the firm started it.

Dec 6, 2017Firm started the recall
Jan 14, 2018FDA classified it Class II
Jan 24, 2018Published in FDA’s Enforcement Report
Nov 4, 2019FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/72391-medtronic-kyphon-express-bone-filler-device-recall-directional-alignment-risk">Medtronic KYPHON Express Bone Filler Device Recall: Directional Alignment Risk (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0352-2018 (December 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0352-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 31, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.