FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1562-2014
- Recalling firm
- AlloSource, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-03-25
- Posted
- 2014-05-06
- Terminated
- 2014-08-11
- 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.
- Lot, serial or model codes
- Lot numbers 132095-603, 608, 609, 611-618, 622-629, 631-634, and 636-638. Lot numbers 132095-604, 619, and 621.
- 510(k) numbers
- ["K071849"]
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 3000215346
- Firm city
- Centennial
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28