Straumann GM Helix dental implant recalled over carton labeling mismatch
Straumann USA is recalling certain GM Helix dental implants (Article No. 109.984, Lot MVXJ9) because the implant inside the package may not match the outer carton label. If the wrong implant is placed, it could cause bone compression or make installation difficult where there is sufficient bone. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Straumann recalls
What to do
- Check the Article No. 109.984 and lot MVXJ9 on implant packaging against the carton label.
- Do not use implants from this lot if the implant does not match its label; contact Straumann USA for guidance.
- Dental professionals with questions should contact Straumann USA LLC directly.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- GM Helix Implant, Endosseous Dental Implant Article No. 109.984
- Sold in
- Nationwide
- Made for
- Adults (18 years to 120 years)
Details
- Units affected
- 417 US
- Illnesses reported
- None reported
- Manufactured in
- 60 Minuteman Rd, Andover, MA, United States
- Classification
- Class II
- Recall number
- Z-2929-2026
In the FDA's words
- Description
- GM Helix Implant, Endosseous Dental Implant Article No. 109.984 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 UDI-DI 7899878024552 Lot MVXJ9 Distribution: US 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. Affected quantity: 417 US
- 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
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