GM Helix Implant, REF: 109.984;
Straumann USA LLC · There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
Open FDA's page for this record- Cfres ID
- 222258
- Product res number
- Z-3173-2026
- Event date initiated
- 2026-08-12
- Event date posted
- 2026-09-15
- Recall status
- Open, Classified
- Res event number
- 99707
- Product code
- DZE
- Product description
- GM Helix Implant, REF: 109.984;
- Code info
- REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;
- Firm FEI number
- 1000121052
- Recalling firm
- Straumann USA LLC
- Address 1
- 60 Minuteman Rd
- City
- Andover
- State
- MA
- Postal code
- 01810-1008
- Additional info contact
- Todd Shevlin 978-759-5442
- Reason for recall
- There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
- Root cause description
- Under Investigation by firm
- Product quantity
- 216
- Distribution pattern
- 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;
- Action
On August 12, 2026, Urgent Field Safety Action letters were sent to customers. Actions to be taken: 1. Identify and segregate any units in your stock with carton packaging labeled as Article 109.984 Helix GM Implant, 4.0 x 11.5 mm, L ot VZPF4 2. If the article is still in your inventory, then stop use/ distribution of the product immediately and quarantine / segregate physically. 3. Please return the affected items to the attention of Todd Shevlin at Straumann USA, LLC for replacement as indicated on the Customer Confirmation Form. 4. If the product has already been implanted, implant removal is not required, and no additional patient follow -up is required solely due to this recall 5. In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided to: Straumann USA, LLC. If product is not being returned, the completed Customer Confirmation Form can be scanned and emailed to todd.shevlin@straumann.com
- K numbers
- K163194
- Harmonized identifiers (openFDA)
- Device name
- Implant, Endosseous, Root-Form
- Medical specialty description
- Dental
- Regulation number
- 872.3640
- Device class
- 2
- K number
- K020617, K900793, K162853, K191895, K091051, K133327, K974358, K953280, K960026, K983742, K952120, K051507, K130221, K964330, K080713, K151391, K063874, K811923, K191201, K070570, K232740, K173975, K160581, K034022, K953000, K071070, K024044, K772304, K902968, K130787, K120043, K914764, K223697, K952917, K963945, K031475, K891617, K140202, K170031, K040946 +1,509 more
- PMA number
- P800035, P860012
- Registration number
- 3011936113, 3001082453, 2023623, 2245590, 3004201263, 3013111692, 2029275, 3006405073, 2032098, 3007518363, 3006592743, 3025517712, 3015775866, 3004049923, 8020776, 9613283, 9611993, 3011587077, 3015160953, 1424785, 3031462380, 3038549074, 2024024, 3008088588, 3014596751, 3011656326, 9680605, 2031884, 8030870, 8010591, 9611992, 2921595, 3005216725, 3024859204, 3008252900, 3009528826, 3011103459, 3009611645, 3011187779, 2183744 +288 more
- FEI number
- 3011936113, 3001082453, 2023623, 3002807692, 2245590, 3004201263, 3013111692, 3006405073, 3007518363, 3006592743, 3025517712, 3015775866, 3003110073, 3004049923, 3002806651, 3011587077, 3003267134, 3015160953, 1000306551, 3031462380, 3038549074, 3000215273, 2024024, 3008088588, 3014596751, 3011656326, 5870, 2921595, 3005216725, 3002807009, 3024859204, 3002806577, 3008252900, 3009528826, 3011103459, 3003054571, 3009611645, 3011187779, 4224, 2183744 +288 more