DeviceSignal · Recall classified
Straumann USA LLC
FDA classified a device recall on 2026-08-10 · Class II · Z-2929-2026
EventRecall classified
Effective2026-08-10
ClassificationClass II
On 2026-08-10 the FDA classified a device recall from Straumann USA LLC as Class II. Product: GM Helix Implant, Endosseous Dental Implant Article No. 109.984. Recall Z-2929-2026. The firm initiated it on 2026-07-13. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2929-2026
- Classification
- Class II
- Classified on
- 2026-08-10
- Initiated on
- 2026-07-13
- Firm
- Straumann USA LLC
- Reason
- There 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
- Product
- GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2929-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
cf438cfac27581cba0de495b7bd76bf102a28eea1e6668768d8f86701f81b96b- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)