Class 2 Device Recall Swedevent

• Date Initiated by Firm: January 13, 2004
• Date Posted: July 23, 2004
• Recall Status: Terminated on September 01, 2004
• Recall Number: Z-1143-04
• Recall Event ID: 28217
• Product Classification: Implant, Endosseous, Root-Form - Product Code DZE
• Product: Swedevent Implant Line
• Code Information: Swedevent Implant Line Part # Description Lot Number Quantity ACBX2 ABUTMENT,SWEDE-VENT,BALL SCREW, 2MM 012689 70 ACBX2 ABUTMENT,SWEDE-VENT,BALL SCREW, 2MM 015188 50 ACBX2 ABUTMENT,SWEDE-VENT,BALL SCREW, 2MM 015778 69 ACBX2 ABUTMENT,SWEDE-VENT,BALL SCREW, 2MM 0200993 71 ACBX4 ABUT,SW-V,BALLSCREW,4.0MM 013174 100 ACBX4 ABUT,SW-V,BALLSCREW,4.0MM 015935 50 ACBX4 ABUT,SW-V,BALLSCREW,4.0MM 0200385 50 ACBX4 ABUT,SW-V,BALLSCREW,4.0MM 0201514 46 ACBX6 ABUT,SW-V,BALLSCREW,6.0MM 016063 33 ACTX3 ABUTMENT,SWEDE-VENT,COLLAR,3MM LONG 012349 75 ACTX3 ABUTMENT,SWEDE-VENT,COLLAR,3MM LONG 015137 50 ACTX3 ABUTMENT,SWEDE-VENT,COLLAR,3MM LONG 017685 50 ACTX4 ABUT,SWEDE-VENT,TAPERED SCREW,4.0MM COLLAR 012926 70 ACTX4 ABUT,SWEDE-VENT,TAPERED SCREW,4.0MM COLLAR 013745 47 ACTX4 ABUT,SWEDE-VENT,TAPERED SCREW,4.0MM COLLAR 015356 50 ACTX4 ABUT,SWEDE-VENT,TAPERED SCREW,4.0MM COLLAR 015496 147 ACTX4 ABUT,SWEDE-VENT,TAPERED SCREW,4.0MM COLLAR 0201165 70 ACTX4 ABUT,SWEDE-VENT,TAPERED SCREW,4.0MM COLLAR 0201943 55 ACTX6 ABUTMENT,SWEDE-VENT,TAPERED SCREW,6.0MM COLLAR 014046 56 AH20X ABUTMENT,PRE-ANGLE HEAD 20 DEG,SWEDE-VENT 013589 100 AH20X ABUTMENT,PRE-ANGLE HEAD 20 DEG,SWEDE-VENT 0203139 40 AH20X/5 ABUTMENT,PRE-ANGLE HEAD 20 DBL HEX,SWEDE-VENT 014278 100 AH20X/5 ABUTMENT,PRE-ANGLE HEAD 20 DBL HEX,SWEDE-VENT 016640 70 AH20X/5 ABUTMENT,PRE-ANGLE HEAD 20 DBL HEX,SWEDE-VENT 0202509 50 FMD Drill, Fixture Mount, Swede-Vent 012988 256 FMD Drill, Fixture Mount, Swede-Vent 013920 300 FMD Drill, Fixture Mount, Swede-Vent 014685 398 GPCA Coping, Gold, Sw-V, Ext Hex Imp 014769 139 GPCA Coping, Gold, Sw-V, Ext Hex Imp 015056 199 GPCA Coping, Gold, Sw-V, Ext Hex Imp 016643 134 GPCAS Scr, Replacement, Sw-V, Gold Coping 013922 100 GPCAS Scr, Replacement, Sw-V, Gold Coping 014614 500 HLAX/4 ABUTMENT,SWEDE-VENT, 013146 313 HLAX/4 ABUTMENT,SWEDE-VENT, 014223 300 HLAX/4 ABUTMENT,SWEDE-VENT, 016350 599 HLAX/5 ABUTMENT,SWEDE-VENT, 013310 149 HLAX/5 ABUTMENT,SWEDE-VENT, 014489 144 HLAX/5 ABUTMENT,SWEDE-VENT, 016845 215 HLAX/5 ABUTMENT,SWEDE-VENT, 017244 148 HLAX/6 ABUTMENT,SWEDE-VENT, 015824 50 HLAXS SCREW,SW-V,HEX-LOCK ABUT 013386 50 PCAL SHEATH,SWEDE-VENT,PLASTIC-LONG 012895 100 PCAL SHEATH,SWEDE-VENT,PLASTIC-LONG 014249 69 PCAL SHEATH,SWEDE-VENT,PLASTIC-LONG 014753 150 PCAL SHEATH,SWEDE-VENT,PLASTIC-LONG 015058 149 PCAL SHEATH,SWEDE-VENT,PLASTIC-LONG 016720 99 PCAX ABUT,SWEDE-VENT,CAST,HEX-PLASTIC 013227 100 PCAX ABUT,SWEDE-VENT,CAST,HEX-PLASTIC 014250 199 PCAX ABUT,SWEDE-VENT,CAST,HEX-PLASTIC 014765 150 PCAX ABUT,SWEDE-VENT,CAST,HEX-PLASTIC 015536 148 PCAX ABUT,SWEDE-VENT,CAST,HEX-PLASTIC 017124 200 SCAX2 ABUT,SW-V,20DEG ANGLEBASE 016816 23 SCCX2 ABUTMENT,SWEDE-VENT, 015340 40 SCCX2 ABUTMENT,SWEDE-VENT, 015784 66 SCCX2 ABUTMENT,SWEDE-VENT, 0201264 72 TPCA ABUTMENT,SW-VENT COPING 0200400 30 TPCA ABUTMENT,SW-VENT COPING 0202433 31 TSA5 ABUTMENT,SW-V,COPING, 015797 30
• Recalling Firm/ Manufacturer: Zimmer Dental Inc; 1900 Aston Ave; Carlsbad CA 92008-7308
• Manufacturer Reason for Recall: Sterility barrier compromised.
• FDA Determined Cause: Other
• Quantity in Commerce: See Codes
• Total Product Life Cycle: TPLC Device Report

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.