medical Class II Updated 2018-09-12

Zimmer Dental Inc recalls Outer Package Label: Tapered Screw-Vent Implant System, 4.1m

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Outer Package Label: LOT: 63781164, UDI: (01) 00889024019621 (10) 63781164 (17) 220930 (10) 63781164; Inner Package Label: LOT: 63773888, UDI: (01) 00889024019508 (17) 220930 (10)63773888.
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