FDA Medical Device Recalls (openFDA)
Zimmer Dental Inc: Tapered Screw-Vent MTX Model TSVTB11
- Recall number
- Z-0284-2018
- Recalling firm
- Zimmer Dental Inc
- Product
- Tapered Screw-Vent MTX Model TSVTB11
- Status
- Terminated
- Initiated
- 2017-11-20
- Posted
- not on file
- Terminated
- 2024-02-28
- Reason
- Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 500 units
- Distribution
- US, Canada, France, Italy, Spain, Germany
- Lot, serial or model codes
- lot,#63519794; UDI: (01)00889024019935 (17)211130 (10)63519794
- 510(k) numbers
- ["K101977"]
- 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