Reported Apr 17, 2019 · Terminated
Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is…
Integra Limited
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: Integra Limited · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- Integra bioBLOCK Resorbable subtaler Implant, 11mm
- Catalog Number040011 -
- Product UsageThe bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot
- Lot codes and dates
- Lot Numbers
FGD2096FGD8328
- Lot Numbers
- Amount recalled
- 232 total
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
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
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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