Z-1140-04

Biovent Implant Line

Name: Z-1140-04 Biovent 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 Biovent 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-1140-04
Status: Terminated
Initiated: 2004-01-13
Posted: 2004-07-23
Terminated: 2004-09-01
Recalling firm: ZimVie US Corp LLC
Product: Biovent 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: 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

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)