Device recall

GM Helix Implant, REF: 109.984;

FDA recall source

Recall number

Z-3173-2026

Event id

99707

Status

Ongoing

FDA classification

Class II

Recalling firm

Straumann USA LLC

Report date

Sep 23, 2026

Posted

Sep 15, 2026

Initiated

Aug 12, 2026

Center classification date

Sep 15, 2026

Product code

DZE

Device type

Implant, Endosseous, Root-Form

Reason

There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.

Root cause

Under Investigation by firm

Quantity

216

Code info

REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;

Distribution

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;

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K163194

Location

Andover, MA, United States