Zimmer Dental Inc: Medical Device Recall in 2018 - (Recall #: Z-1190-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.

Product Classification:

Class II

Date Initiated: November 29, 2017

Date Posted: April 4, 2018

Recall Number: Z-1190-2018

Event ID: 78667

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.

Status: Terminated

Product Quantity: 995 distribution events total

Code Information:

Lot No. 63619437, UDI #(01)00889024019225 (17)220331 (10)63619437.

Distribution Pattern:

Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.

Voluntary or Mandated:

Voluntary: Firm initiated