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U.S. Department of Health and Human Services

Medical Device Recalls
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Product Description
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FDA Recall
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"****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***S... 2 10/24/2012 FEI # 3008592715
Orthosensor
"***3i Incise Custom-Made Label. QP157 Approved 07/09/10*** 3i inc se Custom-made Dental Framework**... 3 07/16/2011 FEI # 1038806
Biomet 3i, LLC
"***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO... 2 10/29/2012 FEI # 1017294
Linvatec Corp. dba ConMed Linvatec
"***Assembled for Invivo Corporation 12501 Research Parkway Orlando FL 32826***Made in U.S.A.***MRI ... 2 10/25/2011 FEI # 1051786
Invivo Corporation
"***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF AC4425***Conical 25 ANGLE... 2 11/03/2011 FEI # 1038806
Biomet 3i, LLC
"***BIOMET 3i***4555 Riverside Drive Palm Beach Gardens FL 33410 USA***REF SWCA62***Conical Abutment... 2 11/03/2011 FEI # 1038806
Biomet 3i, LLC
"***BIOMET MICROFIXATION***CENTER DRIVE STAINLESS STEEL***2.0MM SYSTEM SCREWDRIVER BLADE***Non-Steri... 2 08/01/2011 FEI # 1032347
Biomet Microfixation, Inc.
"***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec,... 2 01/11/2012 FEI # 3004553437
Endotec, Inc.
"***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec,... 2 01/11/2012 FEI # 3004553437
Endotec, Inc.
"***BUECHEL-PAPPAS CRUCIATE SACRIFICING BEARING ***MATERIAL UHMWPe***STERILE EO***ENDOTEC***Endotec,... 2 01/11/2012 FEI # 3004553437
Endotec, Inc.

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