Z-1562-2014Class II

AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for...

Name: Z-1562-2014 AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for...
Creator: AlloSource, Inc.
Published: 2014-03-25
License: https://open.fda.gov/license/

Allosource / initiated 2014-03-25 / Terminated / root cause: manufacturing process

FDA source

AlloSource, Inc. began a recall of 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... on 2014-03-25. FDA classified it as Class II and gives the reason as "The donor was hemodiluted". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1562-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-25
Posted: 2014-05-06
Terminated: 2014-08-11
Recalling firm: Allosource
Product: 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.
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: The donor was hemodiluted.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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
Quantity in commerce: 29
Distribution: Distribution US nationwide, including Michigan and a distributor in Colorado.
Product codes and lots: Lot numbers 132095-603, 608, 609, 611-618, 622-629, 631-634, and 636-638. Lot numbers 132095-604, 619, and 621.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1562-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1562-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-14	2014-05-06

Product code MQV

K071849Class IIAllofuse Gel and PuttyAllosource, Inc. / cleared 2008-12-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)