Recall Z-1034-2009 ยท MQV Filler, Bone Void, Calcium Compound
Integra LifeSciences Corp
Integra Mosaik Putty, 15cc, Catalog # PTY10256 Integra Lifesciences, Plainsboro, NJ
| Date | Mar 6, 2009 (initiated Jan 16, 2009) |
| Status | Terminated |
| Reason | Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained. |
| Root cause | Pending |
| Action | Urgent: Product Recall Notification letters were sent on January 21, 1009 via Federal Express. The letter asked customers to immediately quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and arrangement of product returns. The enclosed "Recall Acknowledgement and Return Form" indicating whether or not customers possess any of the affected product should also be completed and returned. Company is conducting recall to the hospital level. Questions should be directed to Judy O'Grady at 609-936-2317. |
| Quantity | 88 units |
| Distribution | Nationwide Distribution -- including states of FL, CA, GA, FL, CT, MT, IL, TX, WA, TN, NC, IN, AZ, MD, CO, MO, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062353 | MOZAIK BONE REGENERATION MATRIX - PUTTY Integra LifeSciences Corporation, Dec 20, 2006 |