Straumann Manufacturing, Inc.

FDA recalling firm · 4 enforcement events · 11 product records · 2016–2018 · MA

Straumann Manufacturing, Inc. has 4 FDA enforcement events on this register (11 product records) between 2016 and 2018: 4 device; the busiest year was 2016 with 2.

0% of its events are Class I; the most common class is Class II (4). 0 events are listed as ongoing; the recalling firm's address is in MA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
2 Oct 2018	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 gingival heights to match the variations in…	Device	Class II	1	Terminated
23 Mar 2018	Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W	Device	Class II	6	Terminated
23 Nov 2016	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 function on single-tooth and/or multiple…	Device	Class II	2	Terminated
14 Jul 2016	Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510	Device	Class II	2	Terminated

By type and class

Device4

Class II4

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Straumann Manufacturing, Inc. by year initiated.

Questions and answers

How many FDA recalls has Straumann Manufacturing, Inc. had?

4 enforcement events (11 product records) on this register, 2016–2018: 4 device.

Are any Straumann Manufacturing, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Straumann Manufacturing, Inc. recalls?

4 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.