--- title: "Straumann USA LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Straumann USA LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/straumann-usa-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Straumann USA LLC recall records **14** reported ongoing 16 records in this archive. Latest source date Aug 12, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Aug 12, 2026 FDA device enforcement ### [GM Helix Implant, REF: 109.984;](https://isitonrecall.com/recall/fda-device-z-3173-2026-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. Class II Reported ongoing Distribution: US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA, WI; [Official source for GM Helix Implant, REF: 109.984;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3173-2026%22) Jul 16, 2026 FDA device enforcement ### [Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form](https://isitonrecall.com/recall/fda-device-z-2935-2026-straumann-bone-level-tapered-blt-implant-d-4-1mm-rc-slactive-14mm-roxolid-loxim-article-021-5314-imp/) 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. Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 02...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2935-2026%22) Jul 13, 2026 FDA device enforcement ### [GM Helix Implant, Endosseous Dental Implant Article No. 109.984](https://isitonrecall.com/recall/fda-device-z-2929-2026-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 difficulty during installation in situat... Class II Reported ongoing Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX,... [Official source for GM Helix Implant, Endosseous Dental Implant Article No. 109.984](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2929-2026%22) Mar 27, 2026 FDA device enforcement ### [Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments](https://isitonrecall.com/recall/fda-device-z-1994-2026-straumann-n-ce-pmma-full-arch-restoration-screw-retained-bridge-article-010-0304-endosseous-dental-i/) Includes an incorrect screw seat interface. Class II Reported ongoing Distribution: US distribution to AL, AZ, FL, HI, LA, MD, OH, VA. [Official source for Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous De...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1994-2026%22) Mar 27, 2026 FDA device enforcement ### [Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments](https://isitonrecall.com/recall/fda-device-z-1995-2026-straumann-n-ce-zr-ht-full-arch-restoration-article-010-0158-endosseous-dental-implant-abutments/) Includes an incorrect screw seat interface. Class II Reported ongoing Distribution: US distribution to AL, AZ, FL, HI, LA, MD, OH, VA. [Official source for Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1995-2026%22) Mar 17, 2026 FDA device enforcement ### [Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;](https://isitonrecall.com/recall/fda-device-z-1632-2026-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 Gr4 D (SAP #701922 / Lot 7130430). As a... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada. [Official source for Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1632-2026%22) Mar 17, 2026 FDA device enforcement ### [Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;](https://isitonrecall.com/recall/fda-device-z-1633-2026-custom-abutment-as-ti-for-straumann-rc-incl-tan-screw-catalog-number-art-010-5438/) 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 Gr4 D (SAP #701922 / Lot 7130430). As a... Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, CO, FL, IA, IL, MN, MO, MT, OR, WA; and the country of Canada. [Official source for Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1633-2026%22) Jan 6, 2026 FDA device enforcement ### [WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM](https://isitonrecall.com/recall/fda-device-z-1337-2026-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. Class III Reported ongoing Distribution: US Nationwide distribution. [Official source for WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1337-2026%22) Oct 17, 2025 FDA device enforcement ### [Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;](https://isitonrecall.com/recall/fda-device-z-0582-2026-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. Class II Reported ongoing Distribution: US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA. [Official source for Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0582-2026%22) May 1, 2025 FDA device enforcement ### [GM Helix Acqua Implant, Article Number: 140.984](https://isitonrecall.com/recall/fda-device-z-1862-2025-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. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia,... [Official source for GM Helix Acqua Implant, Article Number: 140.984](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1862-2025%22) May 1, 2025 FDA device enforcement ### [GM Helix Acqua Implant, Article Number: 140.985](https://isitonrecall.com/recall/fda-device-z-1863-2025-gm-helix-acqua-implant-article-number-140-985/) It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia,... [Official source for GM Helix Acqua Implant, Article Number: 140.985](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1863-2025%22) Apr 17, 2025 FDA device enforcement ### [WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.](https://isitonrecall.com/recall/fda-device-z-1671-2025-wb-xl-anatomic-healing-abutment-xc-endosseous-dental-implant-abutments/) Incorrect blister labelling. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden. [Official source for WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1671-2025%22) Apr 14, 2025 FDA device enforcement ### [Plus Initial Drill, Article Number: 103.170;](https://isitonrecall.com/recall/fda-device-z-1861-2025-plus-initial-drill-article-number-103-170/) The referred batch was produced without the laser engraving of 7 mm. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, MN, NC, NV, NY, OH, OK, SC, TX, VA, WI and the countries of Brazil, Germany, India, Indonesia, Po... [Official source for Plus Initial Drill, Article Number: 103.170;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1861-2025%22) Mar 8, 2025 FDA device enforcement ### [TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;](https://isitonrecall.com/recall/fda-device-z-1561-2025-tlx-tlc-sp-guided-implant-driver-for-ratchet-stainless-steel-ref-037-3002/) The devices are missing the laser marked depth markings. Class II Reported ongoing Distribution: Worldwide - US Nationwide distribution in the states of CA, IN, ME, MN and the countries of Belgium, Finland, France, Germany, Iceland, Israel, Italy, Latvia, Malta, Romania, Sw... [Official source for TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1561-2025%22) Nov 30, 2021 FDA device enforcement ### [Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089](https://isitonrecall.com/recall/fda-device-z-0512-2022-neodent-easypack-helix-gm-acqua-3-5x8-smart-4-5x2-5-intended-for-dental-implant-item-138-089/) Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant Class II Reported terminated Distribution: US Nationwide Distribution in the states of FL, IL, OH [Official source for Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0512-2022%22) Nov 30, 2021 FDA device enforcement ### [Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107](https://isitonrecall.com/recall/fda-device-z-0513-2022-neodent-easypack-helix-gm-acqua-3-5x13-smart-4-5x2-5-article-number-138-107/) Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant Class II Reported terminated Distribution: US Nationwide Distribution in the states of FL, IL, OH [Official source for Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0513-2022%22) ## Reasons in these listed records - There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside. - 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. - 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 difficulty during installation in situations where there is ... - Includes an incorrect screw seat interface. These examples come from this result page and are not a ranking of every recall reason. ## Checking Straumann USA LLC ### Is there a recall on straumann usa llc right now? This archive contains 16 records, including 14 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Straumann USA LLC](https://isitonrecall.com/check/?q=Straumann%20USA%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)