Z-2391-2020Class II

Medtronic Bone Void Filler, Large -

Name: Z-2391-2020 Medtronic Bone Void Filler, Large -
Creator: Medtronic Sofamor Danek USA Inc
Published: 2020-04-24
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2020-04-24 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic... on 2020-04-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2391-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-24
Posted: 2020-06-16
Terminated: 2021-03-31
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: 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 code: HRX Arthroscope
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Medtronic notified customers on about 04/24/2020 via "URGENT: Voluntary Market Removal (Recall)" letter. Customers were informed that Medtronic was notified by Skeletal Kinetics LLC that product that may not maintain its setting characteristics for the labeled shelf-life duration of the product, which may lead to a longer period of time required for the product to set at the time of implantation. Instructions included to not use the product and locate and removed the impacted product from inventory, complete the provided Customer Confirmation Form and return it via email to [email protected], and contact your Medtronic Sales Representative to coordinate the return and replacement of affected product.
Quantity in commerce: 6 units
Distribution: Nationwide distribution to CA, FL, IL, IN, KY, MN, MO, MT, OH, PA, TX, VA, WA.
Product codes and lots: Product number: C07B; GTIN: 00813845020511; Lot Number: 1127302

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2391-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2389-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16
Z-2390-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16
Z-2391-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-24	2020-06-16

Product code HRX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)