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Biomet 3i, Inc.

Biomet 3i, Inc. Recalls

All product recalls associated with Biomet 3i, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

May 2008

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–4 of 4 recalls

Biomet 3i, Inc.: Navigator System Surgical kit (SGKIT), handles inside of ...

The drill malfunctions while in use. The drill has been observed to become lodged in the handle.

FDAMay 9, 2008Nationwide• Biomet 3i, Inc.

Biomet 3i, Inc.: BIOMET 3i, EP Healing Abutment, REF/Item Number: THA53, 4...

Mis-labeling: Labeled THA53 device packaging may contain ITHA53 devices (The ITHA53 is designed to be used with an internally hexed implant--The THA53 is used with an external hex platform)

FDAFeb 14, 2008Nationwide• Biomet 3i, Inc.

Biomet 3i, Inc.: BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002,...

Mispackaging: The Locator Abutment labeled as LOA002 may contain Catalog/Item # LOA003 product and visa versa

FDAFeb 7, 2008

Nationwide

• Biomet 3i, Inc.

Biomet 3i, Inc.: BIOMET 3i Certain MicroMiniplant Straight Healing Abutmen...

Seating Problems: The Micro-miniplant Straight Healing Abutments do not fully seat onto the restorative platform of the implant leaving a gap between the abutment and the implant.

FDAFeb 6, 2008Nationwide• Biomet 3i, Inc.