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FDAMay 10, 2018device

Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a co...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.

What to do

FDA enforcement status: Terminated

Brands named

zimmer dentalzimmer

UPCs

0088902401962100889024019508

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a co... — Recall Details · AllClear