FDAOctober 11, 2021device
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.
What to do
FDA enforcement status: Terminated
Brands named
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UPCs
7899878024897
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAMagnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance Materials, LLC, 100 Matsonford Road, Suite 200, Radnor, PA 19087, NDC 10106-2448-12026-03-31
- CPSCPersilux Brand Zebra Blinds Recalled Due to Strangulation and Entanglement Hazards and Risk of Serious Injury or Death; Violates Federal Rule for Window Coverings; Sold on Amazon2025-09-25
- FDABio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)2025-04-07
- CPSCNewCosplay Children's Sleepwear Recalled Due to Violation of Federal Flammability Standards and Burn Hazard; Imported by Weihai Juanhai Decoration Material; Sold Exclusively at Amazon.com2023-01-19
- FDAComposiTCP 30 Interference screw D 7- L:25 mm, REF 1100046052021-10-07
- CPSCWilliams Advanced Materials & Chemicals Recalls Three Chemical Products Due to Failure to Meet Child-Resistant Packaging Requirement and Violation of FHSA Labeling Requirement (Recall Alert)2021-05-27
- CPSCGorilla Commerce Recalls Oven Liners Due to Risk of Carbon Monoxide Poisoning (Recall Alert)2020-10-29
- FDANeodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr.2019-12-23
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