CLASS II Device recall · Reported 14 May 2014 · FDA Enforcement Report
AlloFuse DBM Putty 5cc recalled by AlloSource
AlloSource is recalling AlloFuse DBM Putty 5cc, distributed nationwide in the US. The recall was initiated on 25 Mar 2014 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-1562-2014
- FDA event ID
- 67986
- Recalling firm
- AlloSource, Centennial, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Mar 2014
- FDA classified
- 6 May 2014
- Reported
- 14 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Hip & Knee Implants
Timeline
| 25 Mar 2014 | Recall initiated by company | |
| 6 May 2014 | Classified by FDA | +42 days |
| 14 May 2014 | 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
The donor was hemodiluted.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender.
Where it was distributed
Distribution US nationwide, including Michigan and a distributor in Colorado.
Questions about this recall
Is AlloFuse DBM Putty 5cc recalled?
Yes. AlloSource recalled AlloFuse DBM Putty 5cc on 25 Mar 2014. The recall is Class II and its status is Terminated. Recall number Z-1562-2014.
Why was it recalled?
The donor was hemodiluted.
Which lots are affected?
Lot numbers 132095-603, 608, 609, 611-618, 622-629, 631-634, and 636-638. Lot numbers 132095-604, 619, and 621.
Where was it sold?
Distribution US nationwide, including Michigan and a distributor in Colorado.
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.
Other Hip & Knee Implants recalls
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|---|---|---|---|---|---|
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| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |