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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. Source coverage and dates.
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
Class IIReported 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;
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 IIReported ongoing
Distribution: US Nationwide distribution.
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 IIReported 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,...
Includes an incorrect screw seat interface.
Class IIReported ongoing
Distribution: US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
Includes an incorrect screw seat interface.
Class IIReported ongoing
Distribution: US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.
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 IIReported 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.
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 IIReported 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.
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
Class IIIReported ongoing
Distribution: US Nationwide distribution.
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Class IIReported 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,...
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Class IIReported 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,...
Incorrect blister labelling.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Canada, China, Netherlands, and Sweden.
The referred batch was produced without the laser engraving of 7 mm.
Class IIReported 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...
The devices are missing the laser marked depth markings.
Class IIReported 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...
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 IIReported terminated
Distribution: US Nationwide Distribution in the states of FL, IL, OH
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 IIReported terminated
Distribution: US Nationwide Distribution in the states of FL, IL, OH
These examples come from this result page and are not a ranking of every recall reason.
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.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
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.
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 and the agency's current notices.
Use monthly 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.