FDA Enforcement
Class II
Terminated
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
Recall: Z-1190-2018
·
Reported April 4, 2018
Enforcement
- Recall Number
- Z-1190-2018
- Event ID
- 78667
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Zimmer Dental Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 4, 2018
- Initiation Date
- November 29, 2017
- Classification Date
- March 26, 2018
- Termination Date
- February 8, 2019
- Address
- 1900 Aston Ave, Carlsbad, CA, 92008-7308, United States
Description
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
Reason
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Code Info
Lot No. 63619437, UDI #(01)00889024019225 (17)220331 (10)63619437.
Distribution
Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
Quantity
995 distribution events total