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Realize Adjustable Gastric Band Model 2200-X with Injection Port & Applier

by Obtech Medical GmbH

PMA P070009

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 28 Sep 2007

PMA

FDA recalls

None ongoing

19 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP070009 Date28 Sep 2007Approval withdrawnStatusWithdrawn

Recalls

19 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0151-2014 FDA Class II initiated 30 Sep 2013
    • Terminated Z-0149-2014 FDA Class II initiated 30 Sep 2013
    • Terminated Z-0150-2014 FDA Class II initiated 30 Sep 2013

    During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.

  • 16 recalls, same reason

    • Terminated Z-0300-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010
    • Terminated Z-0299-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010
    • Terminated Z-0302-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010
    • Terminated Z-0293-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010
    • Terminated Z-0291-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010
    • Terminated Z-0294-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010
    • Terminated Z-0301-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010
    • Terminated Z-0295-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010
    • Terminated Z-0292-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010
    • Terminated Z-0297-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010
    • Terminated Z-0303-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010
    • Terminated Z-0290-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010
    • Terminated Z-0298-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010
    • Terminated Z-0304-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010
    • Terminated Z-0296-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010
    • Terminated Z-0289-2011 FDA Unclassified (pre-2012) initiated 27 Sep 2010

    The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Full name
Realize Adjustable Gastric Bands with Injection Port & Applier
Trade Name
Realize Adjustable Gastric Band Model 2200-X
Generic Name
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
PMA Number
FDA Product Code
LTI
Device Class
Class III
Advisory Committee
Gastroenterology, Urology
FDA Decision
APWD Approval withdrawn