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.
Read the official notice →- Date
- 2026-05-06
- Country
- United States
- Brand
- Straumann
- Product
- Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
- Classification
- Class II
- Units
- US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-09-23
USStraumann USA LLC recalls GM Helix Implant, REF: 109.984;
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
FDA · DeviceStraumann USA LLCUS Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS,…Official notice →- 2026-08-19
- US
Straumann 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 → - 2026-04-01
- US
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…
FDA · DeviceStraumann USA LLCWorldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL,…Official notice → - 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 →
Other drugs & medical recalls in the United States
- 2026-05-06
- US
Abbott Point Of Care Inc. recalls i-STAT G3+ cartridge; List Number: 03P78-26;
Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than…
FDA · DeviceAbbott Point Of Care Inc.Worldwide distribution - US Nationwide and the countries of Canada, AUSTRIA,…Official notice → - US
Heraeus Medical GmbH (Dental Division) recalls Heraeus, PALAMIX uno. Material Number: 66057893.
Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce…
FDA · DeviceHeraeus Medical GmbH (Dental Division)Worldwide distribution - US Nationwide and the countries of Aland Islands,…Official notice → - US
Beta Bionics, Inc. recalls iLet Bionic Pancreas, REF: BB1001
insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal…
FDA · DeviceBeta Bionics, Inc.US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.Official notice → - US
DEPUY (IRELAND) recalls Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
- US
Immuno-Mycologics, Inc recalls Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium…
Neutralization Buffer may contain contaminants
FDA · DeviceImmuno-Mycologics, IncUS Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA,…Official notice → - US
Becton Dickinson & Co. recalls BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
FDA · DeviceBecton Dickinson & Co.Worldwide distribution - US Nationwide and the country of Hong Kong.Official notice →