medical MODERATE Updated 2026-09-23

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

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Recalled Product

GM Helix Implant, REF: 109.984;

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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