Recall Register

Food, drugs, devices › Firms

Straumann USA LLC

FDA recalling firm · 18 enforcement events · 22 product records · 2012–2026 · MA

Straumann USA LLC has 18 FDA enforcement events on this register (22 product records) between 2012 and 2026: 18 device; the busiest year was 2026 with 6.

0% of its events are Class I; the most common class is Class II (17). 12 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

InitiatedProduct (first record)TypeClassRecordsStatus
12 Aug 2026GM Helix Implant, REF: 109.984;DeviceClass II1Ongoing
16 Jul 2026Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-formDeviceClass II1Ongoing
13 Jul 2026GM Helix Implant, Endosseous Dental Implant Article No. 109.984DeviceClass II1Ongoing
27 Mar 2026Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant AbutmentsDeviceClass II2Ongoing
17 Mar 2026Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;DeviceClass II2Ongoing
6 Jan 2026WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POMDeviceClass III1Ongoing
17 Oct 2025Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;DeviceClass II1Ongoing
1 May 2025GM Helix Acqua Implant, Article Number: 140.984DeviceClass II2Ongoing
17 Apr 2025WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.DeviceClass II1Ongoing
14 Apr 2025Plus Initial Drill, Article Number: 103.170;DeviceClass II1Ongoing
8 Mar 2025TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;DeviceClass II1Ongoing
30 Nov 2021Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089DeviceClass II2Terminated
25 Jun 2021KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005DeviceClass II1Ongoing
27 May 2021Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.DeviceClass II1Terminated
27 Oct 2014Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.DeviceClass II1Terminated
24 Sep 2014Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are…DeviceClass II1Terminated
19 Sep 2014Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for…DeviceClass II1Terminated
11 Jul 2012Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a Straumann Narrow CrossFit CARES ZrO2 Abutment…DeviceClass II1Terminated

By type and class

Device18
Class II17
Class III1

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

Events by year

12
14
16
18
20
22
24
26
Enforcement events for Straumann USA LLC by year initiated.

Questions and answers

How many FDA recalls has Straumann USA LLC had?

18 enforcement events (22 product records) on this register, 2012–2026: 18 device.

Are any Straumann USA LLC recalls ongoing?

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

What class are Straumann USA LLC recalls?

17 Class II, 1 Class III. 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.