Zimmer Dental Inc recalls Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Pa…

Recall date

May 10, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2963-2018

FDA classification

Class II

Brand / firm

Zimmer Dental Inc

Sold / distributed

Worldwide Distribution: US (nationwide) in states of: AL, CA, CO, CT, FL, GA, ID, IL, MA, MD, MI, MN, MO, NH, NJ, NY, PA,TN, TX, UT, VA, and WA; and to countries of: Australia, Bulgaria, Canada, Croatia, France, Germany, Italy, Portugal, and Spain.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.