AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voi
FDA device recall Z-1562-2014 · posted 2014-05-06 · Terminated
Recall details
- Recalling firm
- AlloSource, Inc.
- Reason for recall
- The donor was hemodiluted.
- Action taken
- 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
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 29
- Distribution
- Distribution US nationwide, including Michigan and a distributor in Colorado.
- Date initiated
- 2014-03-25
- Date posted
- 2014-05-06
- Date terminated
- 2014-08-11
- Location
- Centennial, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALLOFUSE GEL AND PUTTY (K071849) | Allosource, Inc. | 2008-12-04 |