FDA-Device2026-09-23Class IIMISBRANDING
Straumann GM Helix Implant recalled for packaging-implant dimension mismatch
What this means
Straumann USA LLC is recalling the GM Helix Implant (REF 109.984) because the product label on the packaging does not match the actual dimensions of the implant inside. This mismatch could lead to use of an incorrect implant size during dental procedures. The affected lot (VZPF4) was distributed nationwide to dental providers.
- If you received this implant lot, do not use it and contact your Straumann distributor for a replacement
- Verify any implants you have in stock against the lot number VZPF4 and UDI listed in this recall
The agency's original wording
Hazard
There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IL, KS, LA, MA, MI, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, VA, WI;
Affected count
216
Manufactured in
60 Minuteman Rd, N/A, Andover, MA, United States
Products
GM Helix Implant, REF: 109.984;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3173-2026Want us to check the next one for you?
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