Class II U.S. Food and Drug Administration

Straumann USA LLC GM Helix Implant, REF: 109.984 recall: There is a discrepancy between the product identification on the packaging

Recall published last month

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

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

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

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3173-2026
Published
September 23, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Straumann USA LLC
Product type
Medical devices
Units affected
216
Distribution
Nationwide
Made in
United States
Lot / code info
REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;
UPC codes
7899878024552

Products covered by this recall

GM Helix Implant, REF: 109.984;

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 7899878024552

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • VZPF4

Model or item number

On the rating label, the box or the instruction sheet.

  • 109.984

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Straumann USA LLC — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Straumann USA LLC — 60 Minuteman Rd, Andover, MA, 01810-1008

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Straumann USA LLC medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 7899878024552; lot code VZPF4; model number 109.984. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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