The Recall Desk

FDA (Devices) recall action 69392

Zimmer Dental Inc recalled 2 products on 2014-11-05

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2014-11-05
Critical
0
Units
2,088

Why these products were recalled

Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2014-11-05

    Zimmer Dental Recalls Spline Twist Implants Due to Labeling Error

    Zimmer Dental is recalling 1,044 Spline Twist Implants because the incorrect diameter size was printed on the inner vial.

    Product
    Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2014-11-05

    Zimmer Dental Recalls Tapered Screw-Vent Implants Due to Labeling Error

    Zimmer Dental is recalling specific Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.

    Product
    Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform Part No. TSV4B11 The Tapered Screw-Vent Implants are designed for use in the maxilla or mandible for immediate loading or f
    Category
    Distribution
    0 states