Recall Z-1562-2014 ยท MQV Filler, Bone Void, Calcium Compound
AlloSource, Inc.
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.
| Date | May 6, 2014 (initiated Mar 25, 2014) |
| Status | Terminated |
| Reason | The donor was hemodiluted. |
| 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 | 29 |
| Distribution | Distribution US nationwide, including Michigan and a distributor in Colorado. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071849 | ALLOFUSE GEL AND PUTTY Allosource, Inc., Dec 4, 2008 |