GM Helix Implant, Endosseous Dental Implant Article No. 109.984
USGM Helix Implant, Endosseous Dental Implant Article No. 109.984
Recalling Firm: Straumann USA LLC
Reason for Recall / Hazard
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 Description & Identification
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Affected Products
GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Additional Source Details
| Field | Value |
|---|---|
| City | Andover |
| State | MA |
| Event id | 99407 |
| Address 1 | 60 Minuteman Rd |
| Code info | UDI-DI 7899878024552 Lot MVXJ9 |
| Postal code | 01810-1008 |
| Report date | 20260819 |
| Product type | Devices |
| Product quantity | 417 US |
| Reason for recall | 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 |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260713 |
| Initial firm notification | Letter |
| Center classification date | 20260810 |
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Overview
- Recalling FirmStraumann USA LLC
- StatusOngoing
- Risk LevelClass II
- 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.
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🚨 SAFETY ALERT: Straumann USA LLC - GM Helix Implant, Endosseous Dental Implant Article No. 109.984 Check if your household is affected: https://therecallfile.com/recalls/gm-helix-implant-endosseous-dental-implant-article-no-109-984/FDA-Z-2929-2026
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