AlloFuse DBM Putty 5cc, Catalog No. 90038005 recallZ-1562-2014 · AlloSource, Inc. · initiated Mar 25, 2014
Class II Terminated All recalls posted in May 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from AlloSource, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The donor was hemodiluted.
FDA root cause category: Process control
What the company is doing
AlloSource sent letter via USPS Certified Mail Receipt to all affected customers dated March 25, 2014, and March 26, 2014. The letter identified the product the problem and the action needed to be taken by the customer. AlloSource requested that the distributor consignee notify subsequent consignees to determine disposition and to request return of unused product. Returned inventory will be quarantined physically and electronically upon receipt. Product initially quarantined and product returned will be destroyed following established procedures. Further questions please call (720) 873-4733
Recall details
- Recall number
- Z-1562-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 25, 2014
- Posted by the FDA
- May 6, 2014
- Recalling firm
- AlloSource, Inc.
- Quantity
- 29
- Product code
- MQV
- FDA submissions
- K071849
- Distribution
- Distribution US nationwide, including Michigan and a distributor in Colorado.
Product description
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.
Code information (models, lots, serial numbers)
Lot numbers 132095-603, 608, 609, 611-618, 622-629, 631-634, and 636-638. Lot numbers 132095-604, 619, and 621.
Other devices under the same FDA submission
1 device cleared under K071849 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- XEMPLIFI 8103.0001SGlobus Medical, Inc. · Filler, bone void, osteoinduction (w/o human growth factor)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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