Tapered Screw-VentRecalls & reported problems across all models
ZimVie US Corp LLC · 131 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13,236
- Deaths reported
- 0
- Injuries reported
- 12,183
- Recalls
- 4
We found 131 models of Tapered Screw-Vent by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 13,236 adverse event reports in the FDA's MAUDE database, received between Sep 4, 2018 and Sep 30, 2026 — classified as 12,183 injuries, 1,053 malfunctions.
The most frequently reported specific device problem is “Fracture” (1,535 reports).
4 FDA recall records name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Tapered Screw-Vent recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 10, 2018Terminated
Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.
Z-2963-2018 · Root cause: Labeling mix-ups · names 2 of these models · Recall details · FDA record ↗
- Nov 29, 2017Terminated
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Z-1190-2018 · Root cause: Packaging process control · Recall details · FDA record ↗
- Nov 29, 2017Terminated
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Z-1189-2018 · Root cause: Packaging process control · Recall details · FDA record ↗
- Nov 20, 2017Terminated
Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
Z-0284-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Tapered Screw-Vent problems
Device problems
- Adverse Event Without Identified Device or Use Problem10,641
- Fracture1,535
- Separation Failure297
- Mechanical Problem241
- Component Missing214
- Patient-Device Incompatibility110
- Unsealed Device Packaging89
- Loss of Osseointegration58
Patient problems
- Unspecified Infection7,338
- Osteolysis5,708
- Pain3,084
- No Clinical Signs, Symptoms or Conditions2,617
- Inflammation2,430
- No Information798
- Abscess626
- Swelling/ Edema572
Tapered Screw-Vent models
131 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Tapered Screw-Vent® TSVB10IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall892 reports
- Tapered Screw-Vent® TSVWB10IMPLANT, ENDOSSEOUS, ROOT-FORM805 reports
- Tapered Screw-Vent® TSVTWB10IMPLANT, ENDOSSEOUS, ROOT-FORM618 reports
- Tapered Screw-Vent TSV4B10IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall562 reports
- Tapered Screw-Vent® TSVB11IMPLANT, ENDOSSEOUS, ROOT-FORM605 reports
- Tapered Screw-Vent® TSVTB10IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall512 reports
- Tapered Screw-Vent® TSVTB11IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall439 reports
- Tapered Screw-Vent® TSVWB8IMPLANT, ENDOSSEOUS, ROOT-FORM415 reports
- Tapered Screw-Vent® TSVB13IMPLANT, ENDOSSEOUS, ROOT-FORM403 reports
- Tapered Screw-Vent TSV4B11IMPLANT, ENDOSSEOUS, ROOT-FORM371 reports
- Tapered Screw-Vent® TSVT4B10IMPLANT, ENDOSSEOUS, ROOT-FORM363 reports
- Tapered Screw-Vent® TSVB8IMPLANT, ENDOSSEOUS, ROOT-FORM356 reports
- Tapered Screw-Vent® TSVTWB11IMPLANT, ENDOSSEOUS, ROOT-FORM326 reports
- Tapered Screw-Vent® TSVWB11IMPLANT, ENDOSSEOUS, ROOT-FORM312 reports
- Tapered Screw-Vent® TSVTB13IMPLANT, ENDOSSEOUS, ROOT-FORM271 reports
- Tapered Screw-Vent® TSVT4B11IMPLANT, ENDOSSEOUS, ROOT-FORM265 reports
- Tapered Screw-Vent® TSVTWB8IMPLANT, ENDOSSEOUS, ROOT-FORM260 reports
- Tapered Screw-Vent® TSV4B8IMPLANT, ENDOSSEOUS, ROOT-FORM258 reports
- Tapered Screw-Vent® TSVMB10IMPLANT, ENDOSSEOUS, ROOT-FORM232 reports
- Tapered Screw-Vent® TSV4B13IMPLANT, ENDOSSEOUS, ROOT-FORM219 reports
- Tapered Screw-Vent® TSVMWB10IMPLANT, ENDOSSEOUS, ROOT-FORM218 reports
- Tapered Screw-Vent® TSVM4B10IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall160 reports
- Tapered Screw-Vent® TSVT6B10IMPLANT, ENDOSSEOUS, ROOT-FORM199 reports
- Tapered Screw-Vent® TSVH10IMPLANT, ENDOSSEOUS, ROOT-FORM194 reports
- Tapered Screw-Vent® TSVWH10IMPLANT, ENDOSSEOUS, ROOT-FORM182 reports
- Tapered Screw-Vent® TSVWB13IMPLANT, ENDOSSEOUS, ROOT-FORM177 reports
- Tapered Screw-Vent® TSVTWB13IMPLANT, ENDOSSEOUS, ROOT-FORM164 reports
- Tapered Screw-Vent® TSVMB11IMPLANT, ENDOSSEOUS, ROOT-FORM158 reports
- Tapered Screw-Vent® TSVT4B13IMPLANT, ENDOSSEOUS, ROOT-FORM158 reports
- Tapered Screw-Vent® TSV6B10IMPLANT, ENDOSSEOUS, ROOT-FORM152 reports
- Tapered Screw-Vent® TSVTB8IMPLANT, ENDOSSEOUS, ROOT-FORM135 reports
- Tapered Screw-Vent® TSVT4B8IMPLANT, ENDOSSEOUS, ROOT-FORM133 reports
- Tapered Screw-Vent® TSVH11IMPLANT, ENDOSSEOUS, ROOT-FORM114 reports
- Tapered Screw-Vent® TSVMWB8IMPLANT, ENDOSSEOUS, ROOT-FORM111 reports
- Tapered Screw-Vent® TSVT6B11IMPLANT, ENDOSSEOUS, ROOT-FORM111 reports
- Tapered Screw-Vent® TSVT6B8IMPLANT, ENDOSSEOUS, ROOT-FORM105 reports
- Tapered Screw-Vent® TSVM4B11IMPLANT, ENDOSSEOUS, ROOT-FORM104 reports
- Tapered Screw-Vent® TSVH13IMPLANT, ENDOSSEOUS, ROOT-FORM103 reports
- Tapered Screw-Vent® TSVB16IMPLANT, ENDOSSEOUS, ROOT-FORM99 reports
- Tapered Screw-Vent® TSVMWB11IMPLANT, ENDOSSEOUS, ROOT-FORM99 reports
- Tapered Screw-Vent® TSVMB13IMPLANT, ENDOSSEOUS, ROOT-FORM92 reports
- Tapered Screw-Vent® TSVWH11IMPLANT, ENDOSSEOUS, ROOT-FORM92 reports
- Tapered Screw-Vent® TSV4H10IMPLANT, ENDOSSEOUS, ROOT-FORM90 reports
- Tapered Screw-Vent® TSVMB8IMPLANT, ENDOSSEOUS, ROOT-FORM80 reports
- Tapered Screw-Vent® TSVM4B8IMPLANT, ENDOSSEOUS, ROOT-FORM79 reports
- Tapered Screw-Vent® TSV6B8IMPLANT, ENDOSSEOUS, ROOT-FORM72 reports
- Tapered Screw-Vent® TSV6H10IMPLANT, ENDOSSEOUS, ROOT-FORM69 reports
- Tapered Screw-Vent® TSVWH8IMPLANT, ENDOSSEOUS, ROOT-FORM69 reports
- Tapered Screw-Vent® TSVWH13IMPLANT, ENDOSSEOUS, ROOT-FORM57 reports
- Tapered Screw-Vent® TSV6B11IMPLANT, ENDOSSEOUS, ROOT-FORM54 reports
- Tapered Screw-Vent® TSVH8IMPLANT, ENDOSSEOUS, ROOT-FORM54 reports
- Tapered Screw-Vent® TSVM6B10IMPLANT, ENDOSSEOUS, ROOT-FORM53 reports
- Tapered Screw-Vent® TSVM4B13IMPLANT, ENDOSSEOUS, ROOT-FORM52 reports
- Tapered Screw-Vent® TSV4H13IMPLANT, ENDOSSEOUS, ROOT-FORM51 reports
- Tapered Screw-Vent® TSVTB16IMPLANT, ENDOSSEOUS, ROOT-FORM45 reports
- Tapered Screw-Vent® TSV6H8IMPLANT, ENDOSSEOUS, ROOT-FORM44 reports
- Tapered Screw-Vent® TSV4B16IMPLANT, ENDOSSEOUS, ROOT-FORM39 reports
- Tapered Screw-Vent® TSV4H11IMPLANT, ENDOSSEOUS, ROOT-FORM37 reports
- Tapered Screw-Vent® TSVMWB13IMPLANT, ENDOSSEOUS, ROOT-FORM36 reports
- Tapered Screw-Vent® TSVWB16IMPLANT, ENDOSSEOUS, ROOT-FORM34 reports
- Tapered Screw-Vent® TSVTWH10IMPLANT, ENDOSSEOUS, ROOT-FORM30 reports
- Tapered Screw-Vent® TSVT6B13IMPLANT, ENDOSSEOUS, ROOT-FORM29 reports
- Tapered Screw-Vent® TSV6H11IMPLANT, ENDOSSEOUS, ROOT-FORM28 reports
- Tapered Screw-Vent® TSV6B13IMPLANT, ENDOSSEOUS, ROOT-FORM25 reports
- Tapered Screw-Vent® HC345ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS24 reports
- Tapered Screw-Vent® TSV4H8IMPLANT, ENDOSSEOUS, ROOT-FORM24 reports
- Tapered Screw-Vent® TSVH16IMPLANT, ENDOSSEOUS, ROOT-FORM24 reports
- Tapered Screw-Vent® TSVMWH10IMPLANT, ENDOSSEOUS, ROOT-FORM24 reports
- Tapered Screw-Vent® TSVM6B8IMPLANT, ENDOSSEOUS, ROOT-FORM22 reports
- Tapered Screw-Vent® TSVTWB16IMPLANT, ENDOSSEOUS, ROOT-FORM22 reports
- Tapered Screw-Vent® TSVTH10IMPLANT, ENDOSSEOUS, ROOT-FORM22 reports
- Tapered Screw-Vent® TSVM6B11IMPLANT, ENDOSSEOUS, ROOT-FORM21 reports
- Tapered Screw-Vent® TSVT4B16IMPLANT, ENDOSSEOUS, ROOT-FORM21 reports
- Tapered Screw-Vent® TSV6H13IMPLANT, ENDOSSEOUS, ROOT-FORM20 reports
- Tapered Screw-Vent® TSVWH16IMPLANT, ENDOSSEOUS, ROOT-FORM20 reports
- Tapered Screw-Vent® TSVMH10IMPLANT, ENDOSSEOUS, ROOT-FORM19 reports
- Tapered Screw-Vent® TSVM4H10IMPLANT, ENDOSSEOUS, ROOT-FORM18 reports
- Tapered Screw-Vent® TSVTWH8IMPLANT, ENDOSSEOUS, ROOT-FORM18 reports
- Tapered Screw-Vent® HC343ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS17 reports
- Tapered Screw-Vent® TSVMB16IMPLANT, ENDOSSEOUS, ROOT-FORM17 reports
- Tapered Screw-Vent® TSVTH13IMPLANT, ENDOSSEOUS, ROOT-FORM16 reports
- Tapered Screw-Vent® HC333ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS11 reports
- Tapered Screw-Vent® TSVM4B16IMPLANT, ENDOSSEOUS, ROOT-FORM11 reports
- Tapered Screw-Vent® TSVT4H10IMPLANT, ENDOSSEOUS, ROOT-FORM11 reports
- Tapered Screw-Vent® TSVMWH11IMPLANT, ENDOSSEOUS, ROOT-FORM8 reports
- Tapered Screw-Vent® TSVT6H13IMPLANT, ENDOSSEOUS, ROOT-FORM8 reports
- Tapered Screw-Vent® TSV4H16IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Tapered Screw-Vent® TSVM6B13IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Tapered Screw-Vent® TSVM4H11IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Tapered Screw-Vent® TSVMH11IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Tapered Screw-Vent® TSVT4H11IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Tapered Screw-Vent® TSVT6H10IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Tapered Screw-Vent® TSVTH11IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Tapered Screw-Vent® TSVTWH13IMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Tapered Screw-Vent® TSVMWH8IMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- Tapered Screw-Vent® TSVTWH11IMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- Tapered Screw-Vent® HC335ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS5 reports
- Tapered Screw-Vent® HC347ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS5 reports
- Tapered Screw-Vent® HC355ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS5 reports
- Tapered Screw-Vent® SRTACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS5 reports
Recent Tapered Screw-Vent adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fracture
Doctor reported the implant was removed due to a fracture. Tooth site 19.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946273 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant at tooth site 33 was removed due to bone loss.
Patient problems: Osteolysis
MAUDE report 50934695 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Osteolysis
MAUDE report 50934017 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported apical abscess on implants, causing bone loss. Tooth sites 32 and 42. Infection was also reported.Procedure completed with another device.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 50932122 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported apical abscess on implants, causing bone loss. Tooth sites 32 and 42.Procedure completed with another device.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 50931992 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant was removed due to a Peri-implantitis, tooth site 46.Patient suffered from inflammation and abscess.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50931940 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant was removed due to Peri-implantitis, tooth site 16.Patient suffered from inflammation and pain.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50931625 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported the patient experienced a failed implant in 2024. A new implant was placed on (b)(6)2025, but the implant site became infected again. The implants were removed and debridement was performed on (b)(6)2025. Tooth site 11,21,25. Implants were removed due to peri-implantitis.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50931183 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported the patient experienced a failed implant in 2024. A new implant was placed on (b)(6)2025, but the implant site became infected again. The implants were removed and debridement was performed on (b)(6)2025. Tooth site 11,21,25. Implants were removed due to peri-implantitis.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50931142 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50931064 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that four implants were removed due to a Peri-implantitis. Patient suffered from inflammation, bone loss and abscess.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50931058 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50931020 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that four implants were removed due to a Peri-implantitis. Patient suffered from inflammation, bone loss and abscess.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50930965 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that four implants were removed due to a Peri-implantitis. Patient suffered from inflammation, bone loss and abscess
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 50930913 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 50930036 ↗
Other ZimVie US Corp LLC products
- OSSEOTITE CERTAIN74 models · 1,891 reports · 1 recall
- TSX Implants28 models · 1,279 reports
- OSSEOTITE73 models · 894 reports
- 3i T3 DCD73 models · 789 reports
- OSSEOTITE CERTAIN PREVAIL15 models · 785 reports
- CERTAIN BELLATEK12 models · 9 reports · 10 recalls
- Eztetic15 models · 382 reports
- Tapered SwissPlus12 models · 376 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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