Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow aspirate, is in
FDA device recall Z-0986-2012 · posted 2012-02-08 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp
- Reason for recall
- Integra OS Osteoconductive Putty is labeled with incorrect storage conditions.
- Action taken
- Integra issued an "Urgent: Product Recall Notification" to customers and sales specialists on 10/7/2011. They were advised of the problem and provided instructions on how to handle the affected product.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 45 units
- Distribution
- Nationwide Distribution - Including the states of CA, OK, MD and VA.
- Date initiated
- 2011-10-07
- Date posted
- 2012-02-08
- Date terminated
- 2013-05-21
- Location
- Plainsboro, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOZAIK BONE REGENERATION MATRIX - PUTTY (K062353) | Integra LifeSciences Corporation | 2006-12-20 |