InterGro PLUS; DBM in a Lipid Carrier with Calcium Granules; Model Numbers: DBM002, DBM005, DBM010, DBMW05 & DBMW10, Int
FDA device recall Z-0618-2008 · posted 2008-02-14 · Terminated
Recall details
- Recalling firm
- Interpore Cross International Inc
- Reason for recall
- Unapproved Testing:Interpore Cross International was recently informed that one of its human tissue suppliers, LifeLink Tissue Bank ("LifeLink"), utilized unapproved diagnostic testing (HBsAg & HBc) on certain lots of distributed donor tissue instead of the FDA approved screening test. As a result, Interpore Cross International has initiated a recall on specific lots of products containing human
- Action taken
- The Recall Notification letters will be sent via commercial carrier (UPS) with signature for verification of receipt required on Friday October 26, 2007, to all consignees, including hospitals and sales representatives, which summarizes the recall details and instructs the consignee to contact Interpore Cross via mail or facsimile with the enclosed Customer Response form, and to immediately return the affected product.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 1,256
- Distribution
- Nationwide
- Date initiated
- 2007-10-15
- Date posted
- 2008-02-14
- Date terminated
- 2008-09-25
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTERGRO DBM (K031399) | Interpore Cross Intl. | 2005-02-18 |