The Recall Desk

FDA (Devices) recall action 75983

Straumann Manufacturing, Inc. recalled 2 products on 2017-01-18

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
2017-01-18
Critical
0
Units
285

Why these products were recalled

Drills cannot be inserted into handpiece due to tolerance specification not met

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)··2017-01-18

    Straumann Dental Implant Drills Recalled for Tolerance Specification Failures

    Straumann Manufacturing is recalling 165 dental implant drills because they cannot be inserted into handpieces due to tolerance specification failures.

    Product
    Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: 044.210 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2017-01-18

    Straumann Twist Drill PRO Recalled for Tolerance Specification Defects

    Straumann Manufacturing is recalling 120 units of Twist Drill PRO dental implant accessories because they cannot be inserted into handpieces due to tolerance specification failures.

    Product
    Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory Article Number: 044.255 Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and f
    Category
    Distribution
    0 states