Device recall

Z-2855-2011: MatriStem Plastic Surgery Matrix XS Intended for implantation to reinforce…

FDA device recall · Class II · ACell, Inc

Key facts

Recall number (Z-number) Z-2855-2011
Recall event 59291
Product MatriStem Plastic Surgery Matrix XS Intended for implantation to reinforce tissue where weakness exists in urological, gynecological, and gastrointestinal anatomy, including, but not limited to the following procedures: pubourethral support, tissue repair, body wall repair, and esophageal repair
Product code FTM
Recalling firm ACell, Inc
Recall class Class II
Status Terminated
Termination date Oct 21, 2011
FEI number 3005920706

At a glance

  • None 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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