Tapered Screw-Vent recallZ-0284-2018 · Zimmer Dental Inc · initiated Nov 20, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer Dental Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
FDA root cause category: Under Investigation by firm
What the company is doing
Recall notification letters will be sent to distributors and clinicians on or about the last week of November 2017. International distributors will be notified via courier or email. Clinicians will be instructed to; 1. Follow any specified patient monitoring instructions, 2. Return Attachment 1 (Acknowledgment of Responsibility) to Zimmer Biomet, 3. Review their inventory and returning any affected product.
Recall details
- Recall number
- Z-0284-2018
- Status
- Terminated
- Initiated by the company
- Nov 20, 2017
- Recalling firm
- Zimmer Dental Inc
- Quantity
- 500 units
- Product code
- DZE
- FDA submissions
- K101977
- Distribution
- US, Canada, France, Italy, Spain, Germany
Product description
Tapered Screw-Vent MTX Model TSVTB11
Code information (models, lots, serial numbers)
lot,#63519794; UDI: (01)00889024019935 (17)211130 (10)63519794
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Tapered Screw-Vent® TSVTB11ZimVie US Corp LLC · IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall439 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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