CLASS II Device recall · Reported 24 Jun 2020 · FDA Enforcement Report
Medtronic Bone Void Filler, Large recalled
Medtronic Sofamor Danek USA is recalling Medtronic Bone Void Filler, Large, distributed nationwide in the US. The recall was initiated on 24 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2391-2020
- FDA event ID
- 85611
- Recalling firm
- Medtronic Sofamor Danek USA, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Apr 2020
- FDA classified
- 16 Jun 2020
- Reported
- 24 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 24 Apr 2020 | Recall initiated by company | |
| 16 Jun 2020 | Classified by FDA | +53 days |
| 24 Jun 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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.
Where it was distributed
Nationwide distribution to CA, FL, IL, IN, KY, MN, MO, MT, OH, PA, TX, VA, WA.
Nationwide CaliforniaFloridaIllinoisIndianaKentuckyMinnesotaMissouriMontanaOhioPennsylvaniaTexasVirginiaWashington
Questions about this recall
Is Medtronic Bone Void Filler, Large recalled?
Yes. Medtronic Sofamor Danek USA recalled Medtronic Bone Void Filler, Large on 24 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-2391-2020.
Why was it 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 lots are affected?
Product number: C07B; GTIN: 00813845020511; Lot Number: 1127302
Where was it sold?
Nationwide distribution to CA, FL, IL, IN, KY, MN, MO, MT, OH, PA, TX, VA, WA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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