Z-1190-2018 Class II Terminated
FDA device recall Z-1190-2018 was initiated by Zimmer Dental Inc on November 29, 2017 and is designated Class II. Reason for recall: Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled. The recall status is terminated (terminated February 8, 2019). Affected quantity: 995 distribution events total.
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- November 29, 2017
- Termination Date
- February 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 995 distribution events total
Product Description
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
Reason for Recall
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Distribution Pattern
Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
Code Information
Lot No. 63619437, UDI #(01)00889024019225 (17)220331 (10)63619437.