Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
Check against the official notice below — it lists the full affected range.
Zimmer Dental Inc. is recalling Tapered Screw-Vent MTX dental implants (Model TSVTB10) because two lots with different outer thread diameters were accidentally mixed together during manufacturing and may have incorrect labels. The affected implants are from Lot No. 63621027, identified by UDI #(01)00889024019928 (17)220331 (10)63619437. The recalled implants were distributed to 995 distribution events across the United States and internationally to Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
The recall notice does not specify a remedy or instructions for 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. 63621027, UDI #(01)00889024019928 (17)220331 (10)63619437.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.