Device recall
Z-0178-2012: LifeCell Strattice Reconstructive Tissue Matrix for Stoma Reinforcement Catalog…
FDA device recall · Class II · LifeCell Corporation
Key facts
| Recall number (Z-number) | Z-0178-2012 |
|---|---|
| Recall event | 60104 |
| Product | 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… |
| Product code | FTM |
| Recalling firm | LifeCell Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 4, 2013 |
| 510(k) numbers | K070560 |
| FEI number | 1000306051 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database