FDA Medical Device Recalls (openFDA)
Zimmer Dental Inc: Swedevent Implant Line
- Recall number
- Z-1143-04
- Recalling firm
- Zimmer Dental Inc
- Product
- Swedevent Implant Line
- Status
- Terminated
- Initiated
- 2004-01-13
- Posted
- 2004-07-23
- Terminated
- 2004-09-01
- Reason
- Sterility barrier compromised.
- Root cause
- Other
- Action
- not on file
- Quantity
- See Codes
- Distribution
- not on file
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 1038806
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28