Dental implants whose box did not match its contents — 57 device records concern packaging (417 units)
For the GM Helix endosseous dental implant, the implant inside the packaging may not match the information on the outer carton label. Installing the incorrect implant could cause bone compression or difficulty during installation where there is sufficient bone volume. The recall covers 417 units in the United States.
Recall overview (primary data)
- ClassificationClass II
- Product typeMedical Device
- Recalling firmStraumann USA LLC
- ReasonThere may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the issue could cause bone compression or difficulty during installation in situations where there is sufficient bone volume
- DistributionUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
- Recall initiated2026-07-13
Key points
- The product is the GM Helix endosseous dental implant, article number 109.984 — 417 units in the United States, distributed across 35 states.
- The reason is a possible mismatch between the implant inside the packaging and the information on the outer carton label.
- Installing the incorrect implant could cause bone compression or difficulty during installation where there is sufficient bone volume.
- The fault is of a kind that the normal step of reading the carton label does not prevent.
- Of the 1,408 recall records this site holds as of 2026-08-28, 72 — 5.1 percent — mention an error or mismatch in labeling.
- Of the 779 device records this site holds as of 2026-09-01, 57 name packaging, 25 assembly and seven something missing.
1What follows when contents and label disagree
A dental implant is a component placed in the jawbone to support an artificial tooth. Its diameter and length are chosen against the volume of bone available, and the operator reads the outer carton to pick the right one. If label and contents disagree, a component other than the one selected goes into bone.
The record states this could cause bone compression or difficulty during installation where there is sufficient bone volume. Even noticing mid-procedure leaves the burden of undoing work already done.
2Faults you can check for, and faults you cannot
What makes this case awkward is that ordinary care by the operator does not prevent it. The step of reading the carton was performed correctly; it is the label that differs from the object. When a quality failure occurs at the packaging stage, attentiveness at the point of use cannot make up for it.
That recalls of this kind run by packaging lot is partly because good and bad units cannot be told apart by inspecting them individually.
3Label mismatches appear in 72 of 1,408 records
Of the 1,408 FDA recall records this site holds as of 2026-08-28, 72 — 5.1 percent — mention an error or mismatch in labeling. In food the prominent category is undeclared allergens at 105 records, but that is a risk borne by the person eating. A label mismatch in a device creates a different shape of problem: the professional using it judges correctly and the outcome still differs.
Which products were exchanged for which, and where in the packaging process the cause lies, are not part of this record.
4Fifty-seven device records concern packaging
Of the 779 device records this site holds as of 2026-09-01, 57 name packaging in the reason for recall, 25 name assembly and seven name something missing.
A device can be made correctly and still go into the wrong box, and the person using it cannot check the contents against the label. For a product implanted in the body, as here, the marking on the box is the only carrier of dimensions and specification, so a packaging error becomes the path to harm directly.
Why it matters
A mismatch between contents and label is a class of fault that no amount of procedural discipline at the point of use will catch, so tightening checks does not address it. Control at the packaging stage maps directly onto safety at the bedside, and because individual units cannot be judged, the recall has to run by lot.
FAQ
What is a dental implant?
Why can care at the point of use not prevent it?
Which products were exchanged?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2929-2026