Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0150-2014 — Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity

U.S. FDA — Device Enforcement · United States · 2013-09-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0150-2014
Date of alert
2013-09-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ethicon Endo-Surgery Inc
Product category
device
Product type
Devices
Reported risk: During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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