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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Event Detail

Event ID 67986
Product Type Devices
Status Ongoing
Recalling Firm AlloSource, Inc.
City Centennial
State CO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-25
Initial Firm Notification of
Consignee or Public
Distribution Pattern Distribution US nationwide, including Michigan and a distributor in Colorado.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot numbers 132095-603, 608, 609, 611-618, 622-629, 631-634, and 636-638. Lot numbers 132095-604, 619, and 621. Class II The donor was hemodiluted. 29 Z-1562-2014