Device recall

Z-2623-2010: Strattice Reconstructive Tissue Matrix for Stoma Reinforcement. 8 cm x 8 cm…

FDA device recall · Class III · LifeCell Corporation

Key facts

Recall number (Z-number) Z-2623-2010
Recall event 56261
Product 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…
Product code FTM
Recalling firm LifeCell Corporation
Recall class Class III
Status Terminated
Termination date Oct 1, 2010
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

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