Recall Z-2623-2010 ยท FTM Mesh, Surgical
LifeCell Corporation
Strattice Reconstructive Tissue Matrix for Stoma Reinforcement. 8 cm x 8 cm Packaged in an inner foil pouch inside outer foil pouch tertiary carton. LifeCell Corporation, One Millennium Way, Branchburg, NJ 08876 Strattice is intended for use as a foil tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is used for
| Date | Sep 29, 2010 (initiated Jul 12, 2010) |
| Status | Terminated |
| Reason | Mislabeled -One lot of product labeled as 8 cm x 8 cm were actually cut using a 6 cm x 6 cm template. |
| Root cause | Employee error |
| Action | LifeCell issued Recall Notice letters dated July 12, 2010 to customers, identifying the affected product, the labeling issue, and actions to be taken by the customer. Two versions of the recall notification were sent, one for implanted units and one for those not yet implanted. Both letters stated that the mislabeling has no impact of the safety or effectiveness of the medical device. Replacement units were offered for all affected units. Those with unused units were to contact LifeCell Customer Solutions for return and replacement of the unit at 1-866-423-2433. Those with implanted unit |
| Quantity | 32 units |
| Distribution | Nationwide Distribution: USA, including the states of AZ, DC, FL, GA, ID, IL, KY, LA, MO, NC, OH, OK, OR, TX, WA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070560 | LRTM SURGICAL MESH Lifecell Corp., Jun 11, 2007 |