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Terminated

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.

FDA Recall Z-1562-2014 · Posted 2014-05-06

Recalling FirmAlloSource, Inc.
Recall StatusTerminated
Product CodeMQV
Date Initiated2014-03-25
Date Terminated2014-08-11
Product Quantity29

Reason for Recall

The donor was hemodiluted.

Firm 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

Root Cause

Process control

Distribution Pattern

Distribution US nationwide, including Michigan and a distributor in Colorado.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071849ALLOFUSE GEL AND PUTTYAllosource, Inc. · 2008-12-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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