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Class 2 Device Recall Biovent |
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Date Initiated by Firm |
January 13, 2004 |
Date Posted |
July 23, 2004 |
Recall Status1 |
Terminated 3 on September 01, 2004 |
Recall Number |
Z-1140-04 |
Recall Event ID |
28217 |
Product Classification |
Implant, Endosseous, Root-Form - Product Code DZE
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Product |
Biovent Implant Line |
Code Information |
BioVent Implant Line Part # Description Lot Number Quantity BV10 IMPLANT,BIO-VENT,INT HEX,HA,10MM L 014528 294 BV10 IMPLANT,BIO-VENT,INT HEX,HA,10MM L 017357 81 BV10 IMPLANT,BIO-VENT,INT HEX,HA,10MM L 017725 89 BV10 IMPLANT,BIO-VENT,INT HEX,HA,10MM L 02000087 196 BV10W Imp, Bio-Vent, HA, 4.5mm, 10mm 014684 112 BV10W Imp, Bio-Vent, HA, 4.5mm, 10mm 016795 89 BV10W Imp, Bio-Vent, HA, 4.5mm, 10mm 017488 90 BV10W Imp, Bio-Vent, HA, 4.5mm, 10mm 0200201 93 BV13 IMPLANT,BIO-VENT,INT HEX,HA,13MM L 013178 300 BV13 IMPLANT,BIO-VENT,INT HEX,HA,13MM L 014531 382 BV13 IMPLANT,BIO-VENT,INT HEX,HA,13MM L 017726 51 BV13 IMPLANT,BIO-VENT,INT HEX,HA,13MM L 0200685 96 BV13 IMPLANT,BIO-VENT,INT HEX,HA,13MM L 0200861 243 BV13W IMPLANT,BIO-VENT,INT HEX,WIDE,HA,13MM L 012359 87 BV13W IMPLANT,BIO-VENT,INT HEX,WIDE,HA,13MM L 013829 98 BV13W IMPLANT,BIO-VENT,INT HEX,WIDE,HA,13MM L 015111 99 BV13W IMPLANT,BIO-VENT,INT HEX,WIDE,HA,13MM L 016955 85 BV16 Imp, Bio-Vent, HA, 3.5mm, 16mm 017703 50 BV16 Imp, Bio-Vent, HA, 3.5mm, 16mm 0200088 94 BV8 IMPLANT,BIO-VENT,INT HEX,HA,8MM L 012855 41 BV8 IMPLANT,BIO-VENT,INT HEX,HA,8MM L 014484 80 BV8W Imp, Bio-Vent, HA, 4.5mm, 8mm 017587 42 BV8W Imp, Bio-Vent, HA, 4.5mm, 8mm 0201661 39 BVT13 IMPLANT,B-V,INT HEX,1MM CLR,TPS,13MM L 0201113 36 BVT13W Imp, Bio-Vent, TPS, 4.5mm, 13mm 0200249 50 BVT16 Imp, Bio-Vent, TPS, 3.5mm, 16mm 0200250 50 BVT16W Imp, Bio-Vent, TPS, 4.5mm, 16mm 0201145 100 |
Recalling Firm/ Manufacturer |
Zimmer Dental Inc 1900 Aston Ave Carlsbad CA 92008-7308
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Manufacturer Reason for Recall |
Sterility barrier compromised.
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FDA Determined Cause 2 |
Other |
Quantity in Commerce |
See Codes |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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