Reported Nov 13, 2013 · Terminated
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage:…
Ethicon Endo-Surgery Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon Endo-Surgery Inc · 4545 Creek Rd · Cincinnati, OH · 45242-2803
Is this the product you have?
- Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids
- Product UsageIntended for use in surgical treatment of morbid obesity
- Lot codes and dates
- The following product code and lot
- numbers were affected by this recallProduct
- Codes2200-X
- Lot NumbersZLGBC5, ZLNBCW, ZLNBJC, ZLPBB9, ZMBBBB, ZMCBBC, ZMGBCJ, ZMHBBT, ZMHBCV, ZMLBD0, ZMMBCD, ZMPBBC, ZNCBC6, ZNGBB3, and ZNGBBF
- Amount recalled
- Product Code: 2200-X - 2,475 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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