Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 24, 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 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 incr…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Sofamor Danek USA Inc recalled Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and bio… - a moderate-severity action.
Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and bio… was recalled by Medtronic Sofamor Danek USA Inc in June 24, 2020. Reason: Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to lon…. Check the official notice for the remedy. Verify recall #Z-2389-2020 with the FDA Devices before acting.
The recall
Medtronic Sofamor Danek USA Inc issued this moderate-severity FDA Devices recall-Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to lon….
- Moderate
- severity level
- 41 units
- affected scope
- Class II
- classification
- June 24, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2389-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2389-2020) was formally reported on June 24, 2020, with the manufacturer initiating the action on April 24, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Sofamor Danek USA Inc is listed as the recalling firm, operating out of Memphis, TN. Federal records list the affected scope as 41 units.
The documented reason for this recall is: 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 anesthesi… Distribution data in the federal record shows the product reached: Nationwide distribution to CA, FL, IL, IN, KY, MN, MO, MT, OH, PA, TX, VA, WA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
41 units
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2389-2020 |
| Date reported | June 24, 2020 |
| Date initiated | April 24, 2020 |
| Recalling firm | Medtronic Sofamor Danek USA Inc |
| Firm location | Memphis, TN |
| Affected scope | 41 units |
| Distribution | Nationwide distribution to CA, FL, IL, IN, KY, MN, MO, MT, OH, PA, TX, VA, WA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2389-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Sofamor Danek USA Inc. Units affected: 41 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 24, 2020. Severity: Moderate. Recall number: Z-2389-2020.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution to CA, FL, IL, IN, KY, MN, MO, MT, OH, PA, TX, VA, WA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2389-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Arizer Solo III Portable Vaporizers Recalled Due to Fire and Burn Hazards; Risk of Serious Injury or Death; Imported by…
· 2026-06-18
FDA Devices Moderate
GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Product Code KSA; used i…
GE Medical Systems Information Technologies Inc · 2026-06-03
FDA Devices Critical
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOCK TRAY, Medline Kit…
Medline Industries, LP · 2026-06-03
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 24, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.