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 Pac

Recalled September 12, 2018 · FDA recall Z-2963-2018 · Zimmer Dental

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. · FDA Class II

Units

299 units

Sold at

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.

Description

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.

Product

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.

Manufacturer(s)

Zimmer Dental Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →