The Recall Desk

Manufacturer

Straumann Manufacturing, Inc.

11 recalls in our database name Straumann Manufacturing, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
11
Critical
0
Severe
0
Most recent
2018-11-21

Of the 11 recalls from Straumann Manufacturing, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–11 of 11

  • ModerateFDA (Devices)·Z-0455-2019·2018-11-21

    Straumann Recalls Neodent GM Mini Conical Abutments Due to Label Mismatch

    Straumann Manufacturing is recalling 21 units of Neodent GM Mini Conical Abutments because the laser-engraved label does not match the item in the package.

    Product
    Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingiva
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1695-2018·2018-05-16

    Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Change

    Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf life change was made without submitting data to demonstrate continued product efficacy.

    Product
    Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1697-2018·2018-05-16

    Straumann Emdogain Recalled for Unverified Raw Material Shelf Life Change

    Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf-life change was implemented without submitting data to demonstrate continued product efficacy.

    Product
    Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1694-2018·2018-05-16

    Straumann Emdogain Recall Due to Shelf Life Data Issue

    Straumann Manufacturing is recalling specific lots of Emdogain because a raw material shelf life change was made without data proving the product remains effective.

    Product
    Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1693-2018·2018-05-16

    Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Changes

    Straumann Manufacturing is recalling Emdogain Enamel Matrix Derivative because a raw material shelf life change was implemented without submitting data to demonstrate continued product efficacy.

    Product
    Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1696-2018·2018-05-16

    Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Changes

    Straumann Manufacturing is recalling Emdogain multipacks because a raw material shelf-life change was implemented without submitting data to demonstrate continued product efficacy.

    Product
    Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1698-2018·2018-05-16

    Straumann Emdogain Recalled Due to Unverified Raw Material Shelf Life Changes

    Straumann Manufacturing is recalling Emdogain 0.7 ml Multipacks because a raw material shelf life change was implemented without submitting data to demonstrate continued product efficacy.

    Product
    Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0957-2017·2017-01-18

    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
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0958-2017·2017-01-18

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2535-2016·2016-08-24

    Straumann Bone Level Implant Recalled for Misalignment with Transfer Piece

    Straumann Manufacturing, Inc. is recalling 33 Bone Level Implants due to misalignment with the Loxim transfer piece markings, which may result in incorrect implant positioning.

    Product
    Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2534-2016·2016-08-24

    Straumann Bone Level Implant Recalled for Misalignment with Transfer Piece

    Straumann Manufacturing is recalling 70 Bone Level Implants because misalignment with the Loxim transfer piece may result in incorrect implant positioning.

    Product
    Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
    Category
    Medical Device
    Distribution
    Distributed nationwide