Recall Z-1562-2014— AlloSource, Inc.

Name: FDA recall Z-1562-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-25

Class II · Terminated

Class II FDA medical device recall by AlloSource, Inc., initiated 2014-03-25, terminated 2014-08-11. It names one FDA 510(k) clearance: K071849. 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.. Reason: The donor was hemodiluted..

Recalling firm: AlloSource, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-03-25
Terminated: 2014-08-11
Firm location: Centennial, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K071849 — ALLOFUSE GEL AND PUTTYAllosource, Inc.·cleared 2008-12-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

The donor was hemodiluted.

Data sourced from openFDA. This site is unofficial and independent of the FDA.