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U.S. Department of Health and Human Services

Class 2 Device Recall AlloFuse DBM Putty 5cc

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 Class 2 Device Recall AlloFuse DBM Putty 5ccsee related information
Date Initiated by FirmMarch 25, 2014
Date PostedMay 06, 2014
Recall Status1 Terminated 3 on August 11, 2014
Recall NumberZ-1562-2014
Recall Event ID 67986
510(K)NumberK071849 
Product Classification Filler, bone void, calcium compound - Product Code MQV
ProductAlloFuse 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 Lot numbers 132095-603, 608, 609, 611-618, 622-629, 631-634, and 636-638. Lot numbers 132095-604, 619, and 621.
FEI Number 3000215346
Recalling Firm/
Manufacturer		 AlloSource, Inc.
6278 S Troy Cir
Centennial CO 80111-6422
For Additional Information ContactTrevor Wright
720-873-4733
Manufacturer Reason
for Recall		The donor was hemodiluted.
FDA Determined
Cause 2		Process control
ActionAlloSource 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 Commerce29
DistributionDistribution US nationwide, including Michigan and a distributor in Colorado.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MQV
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