Z-1143-04

Swedevent Implant Line

Name: Z-1143-04 Swedevent Implant Line
Creator: Zimmer Dental Inc
Published: 2004-01-13
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2004-01-13 / Terminated / root cause: sterility

FDA source

Zimmer Dental Inc began a recall of Swedevent Implant Line on 2004-01-13. The reason FDA records is "Sterility barrier compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1143-04
Status: Terminated
Initiated: 2004-01-13
Posted: 2004-07-23
Terminated: 2004-09-01
Recalling firm: ZimVie US Corp LLC
Product: Swedevent Implant Line
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Sterility barrier compromised.
Root cause tag: sterility
FDA root cause: Other
Quantity in commerce: See Codes
Product codes and lots: 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

Product code DZE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)