Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
Check against the official notice below — it lists the full affected range.
Zimmer Dental Inc. is recalling Tapered Screw-Vent MTX dental implants (Model TSV4B10) from Lot No. 63619437 due to a manufacturing error in which two lots with different outer thread diameters were accidentally mixed together and may have incorrect labels. The affected implants were distributed worldwide across 995 distribution events to the United States and international locations including Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
The mislabeling could result in implants being selected with incorrect dimensions for surgical placement. The recall record does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
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: Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan. Quantity: 995 distribution events total Lot/code info: Lot No. 63619437, UDI #(01)00889024019225 (17)220331 (10)63619437.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.