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Z-3173-2026Class II

Straumann USA LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Straumann USA LLC
Product type
Device
Status
Ongoing
Report date
2026-09-23
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;
Firm state
MA
Product quantity
216
Initiated by
Voluntary: Firm initiated
Reason for recall

There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.

Product description

GM Helix Implant, REF: 109.984;

Code / lot info

REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →