Z-1562-2014 Class II Terminated
FDA device recall Z-1562-2014 was initiated by AlloSource, Inc. on March 25, 2014 and is designated Class II. Reason for recall: The donor was hemodiluted. The recall status is terminated (terminated August 11, 2014). Affected quantity: 29.
Recall Details
- Product Type
- Devices
- Report Date
- May 14, 2014
- Initiation Date
- March 25, 2014
- Termination Date
- August 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29
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.
Distribution Pattern
Distribution US nationwide, including Michigan and a distributor in Colorado.
Code Information
Lot numbers 132095-603, 608, 609, 611-618, 622-629, 631-634, and 636-638. Lot numbers 132095-604, 619, and 621.