Food, drugs, devices › Straumann Manufacturing, Inc.
Device recall: Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be i
FDA enforcement event 81456 is a device recall by Straumann Manufacturing, Inc. of Andover, MA, initiated 2 Oct 2018 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 28 Jan 2019. Initiation: voluntary: firm initiated. Straumann Manufacturing, Inc. has 4 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Straumann Manufacturing, Inc., Andover, MA.
Reason for recall
"Laser engraved label does not match with the item in the package"
Distribution
"US nationwide distribution in the states of GA, TX , VA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0455-2019 | 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… | 21 units | Class II | Terminated | 21 Nov 2018 |
Context
Other enforcement events for Straumann Manufacturing, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Mar 2018 | Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075.098W | Device | Class II | 6 |
| 23 Nov 2016 | Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant accessory Article Number: 044.210 Dental imp | Device | Class II | 2 |
| 14 Jul 2016 | Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510 | Device | Class II | 2 |
All 4 events for Straumann Manufacturing, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Laser engraved label does not match with the item in the package"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US nationwide distribution in the states of GA, TX , VA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 28 Jan 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.