CLASS II ONGOING Device recall · Reported 29 Nov 2023 · FDA Enforcement Report
DBX Demineralized Bone Matrix Putty 10cc-Indicated recalled
Musculoskeletal Transplant Foundation is recalling DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created, distributed nationwide in the US. The recall was initiated on 22 Sep 2023 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-0323-2024
- FDA event ID
- 93296
- Recalling firm
- Musculoskeletal Transplant Foundation, Edison, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Sep 2023
- FDA classified
- 17 Nov 2023
- Reported
- 29 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 22 Sep 2023 | Recall initiated by company | |
| 17 Nov 2023 | Classified by FDA | +56 days |
| 29 Nov 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100
Where it was distributed
US Nationwide distribution in the states of PA, TX, WA.
Questions about this recall
Why was it recalled?
Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.
Which lots are affected?
GUID: W4184038100T0473 Serial #s: 002220854711400006 002220854711400056 002220854711400003 002220854711400008 002220854711400009 002220854711400001 002220854711400002 002220854711400010 002220854711400011 002220854711400012 002220854711400013 002220854711400014 002220854711400004 002220854711400005 002220854711400007 Exp.Date: June 20, 2025
Where was it sold?
US Nationwide distribution in the states of PA, TX, 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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|---|---|---|---|---|---|
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