Straumann USA LLC: GM Helix Implant, REF: 109.984;

Is my product affected?

GM Helix Implant, REF: 109.984;

• UPC 7899878024552

Check against the official notice below — it lists the full affected range.

Hazard

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

Details from the source

Reason for recall: There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside. 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; Quantity: 216 Lot/code info: REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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