Lower riskMedical device recall · FDA · Published April 24, 2020
Medtronic Bone Void Filler May Not Set Properly; Recalled for Longer Surgery Time
Medtronic recalls small bone void filler that may not set correctly, leading to longer surgery and potential bone healing issues. Affected units have specific product numbers and lot numbers.
Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
“Medtronic Bone Void Filler May Not Set Properly; Recalled for Longer Surgery Time.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65298-medtronic-bone-void-filler-may-not-set-properly-recalled-for. Based on FDA recall #Z-2390-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2390-2020%22&limit=1).
The FDA announced on April 24, 2020, that Medtronic Sofamor Danek USA Inc is recalling Medtronic Bone Void Filler, Small due to potential setting characteristic failures. The agency said the device may not maintain its labeled shelf-life duration.
How to tell if you have it
Medtronic Bone Void Filler, Small
UPC 00813845020504
Lot Number 1127301
The hazard
The product may not maintain its setting characteristics for the labeled shelf-life duration, potentially increasing surgical and anesthesia time. If the device seeps or creeps before setting, it could cause incomplete void filling, leading to incomplete bone formation, delayed union, or nonunion.
Context
GovInfoNow's records show Medtronic Sofamor Danek USA Inc has 19 other recalls on record since December 6, 2017. Recent brand recalls include a September 16, 2025, recall of an expandable interbody system cage and a September 26, 2023, recall of Grafton DBM due to Tyvek pouch inspection issues. Other recent recalls of similar products include Orthorebirth BioCera Fibers Bone Filler (March 25, 2026), Orthorebirth ZENBONE Bone Filler (March 25, 2026), and IsoTis OsteoBallast Spine Implants (July 2, 2026).
How to tell if you have this one
Check for product number C07A or lot number 1127301 on the packaging. This product was sold as an injectable bone filler for spinal or joint surgeries.
Brand
Medtronic
Product
Medtronic Bone Void Filler, Small
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Nationwide distribution to CA, FL, IL, IN, KY, MN, MO, MT, OH, PA, TX, VA, WA.
Recall number
Product, codes & lots
Quantity
Z-2389-2020
Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.; Product number: EL153B; GTIN: 00643169157248; Lot Number: 0009541707
41 units
Z-2390-2020
Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.; Product number: C07A; GTIN: 00813845020504; Lot Number: 1127301
36 units
Z-2391-2020
Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.; Product number: C07B; GTIN: 00813845020511; Lot Number: 1127302
6 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for product number C07A or lot number 1127301 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 13 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Nationwide distribution to CA, FL, IL, IN, KY, MN, MO, MT, OH, PA, TX, VA, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Illinois, Indiana, Kentucky, Minnesota, Missouri, Montana, Ohio, Pennsylvania, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2390-2020 (April 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2390-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.