Straumann USA LLC recalls Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti…
Read the official notice →- Date
- 2026-04-01
- Country
- United States
- Brand
- Straumann
- Product
- Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Straumann recalls
- 2026-08-19
USStraumann USA LLC recalls Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest.
- US
Straumann USA LLC recalls GM Helix Implant, Endosseous Dental Implant Article No. 109.984
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or…
FDA · DeviceStraumann USA LLCUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice → - 2026-05-06
- US
Straumann USA LLC recalls Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
Includes an incorrect screw seat interface.
- 2026-02-18
- US
Straumann USA LLC recalls WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
- 2025-12-03
- US
Straumann USA LLC recalls Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
FDA · DeviceStraumann USA LLCUS Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX,…Official notice → - 2025-06-04
- US
Straumann USA LLC recalls GM Helix Acqua Implant, Article Number: 140.984
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
FDA · DeviceStraumann USA LLCWorldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il…Official notice →
Other drugs & medical recalls in the United States
- 2026-04-01
- US
Tandem Diabetes Care, Inc. recalls Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven…
The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead…
FDA · DeviceTandem Diabetes Care, Inc.International distribution in the countries of Czech Republic, Slovakia.Official notice → - US
Medtronic MiniMed, Inc. recalls MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or…
FDA · DeviceMedtronic MiniMed, Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - US
AMO Puerto Rico Manufacturing, Inc. recalls Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with TECNIS…
Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.
FDA · DeviceAMO Puerto Rico Manufacturing, Inc.U.S Nationwide distribution in the states of CA,FL, IL, ME,MS, NJ, NY, OK, OR,…Official notice → - US
Koven Technology, Inc. recalls Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device);…
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
FDA · DeviceKoven Technology, Inc.US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO,…Official notice → - US
Orthalign, Inc recalls Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
- US
Philips Ultrasound, Inc recalls Philips S5-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.