Recall Z-0178-2012 ยท FTM Mesh, Surgical
LifeCell Corporation
LifeCell Strattice Reconstructive Tissue Matrix for Stoma Reinforcement Catalog #0606008 (6 x 6 cm), 0808008 (8 cm x 8 cm), (0610008 ( 6 cm x 10 cm). Intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.
| Date | Nov 9, 2011 (initiated Jul 13, 2011) |
| Status | Terminated |
| Reason | The use of Strattice for stoma reinforcement at the time of stoma creation is not within the product's cleared indications for use in the US market. |
| Root cause | PMA |
| Action | LifeCell began notifying their customers via phone on 7/13/2011. Recall Notice Letters and return response forms, dated July 12, 2011, were sent out on the same day. The letter identified the affected product and informed customers of the reason for the recall. Customers were asked to examine their inventory and quarantine the affected product. If customers have affected product, they were to contact Customer Solutions at 1-866-423-2433 to arrange for return of the product to LifeCell. Also, the attached Recall Notification form should have been completed and returned no later than August |
| Quantity | 2651 sublots (of 42 lots) |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070560 | LRTM SURGICAL MESH Lifecell Corp., Jun 11, 2007 |