GM Helix Implant, Endosseous Dental Implant Article No. 109.984
Straumann USA LLC · 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 implan…
Open FDA's page for this record- Cfres ID
- 221503
- Product res number
- Z-2929-2026
- Event date initiated
- 2026-07-13
- Event date posted
- 2026-08-10
- Recall status
- Open, Classified
- Res event number
- 99407
- Product code
- NHA
- Product description
- GM Helix Implant, Endosseous Dental Implant Article No. 109.984
- Code info
- UDI-DI 7899878024552 Lot MVXJ9
- 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 978-747-2560
- Root cause description
- Under Investigation by firm
- 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
- Action
On July 13, 2026, the firm began notifying customers through a combination of mail, phone, and email. Letters were sent via overnight UPS delivery. Customers were instructed to check their inventory for the affected article/project numbers. If the product is still in inventory, customer should stop use or distribution immediately and quarantine/segregate physically. Product should be returned to Straumann USA, LLC for replacement. If the product has already been implanted, the firm states that implant removal is not required, and no additional patient follow up is required solely due to this recall.
- Distribution pattern
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.
- K numbers
- K163194
- Harmonized identifiers (openFDA)
- Device name
- Abutment, Implant, Dental, Endosseous
- Medical specialty description
- Dental
- Regulation number
- 872.3630
- Device class
- 2
- K number
- K252944, K122192, K230143, K061177, K032498, K111199, K132749, K251497, K970073, K150203, K925349, K171757, K151375, K031719, K072642, K061277, K040573, K091904, K200193, K052823, K101890, K231753, K253312, K222913, K242245, K033346, K143515, K191152, K141457, K082545, K173120, K240982, K081575, K242703, K052272, K073540, K072572, K234018, K232170, K203750 +673 more
- Registration number
- 3011936113, 3004748290, 3001082453, 2245590, 3004201263, 3013111692, 2029275, 3038715999, 1531062, 2032098, 3013551048, 3007518363, 3006592743, 3008517893, 3015775866, 8020776, 9613283, 9611993, 3004883837, 3011587077, 3019252621, 3014270094, 3015160953, 1424785, 3039641923, 3031462380, 3038549074, 2024024, 3008088588, 3014596751, 3027595870, 3011656326, 9680605, 8010591, 3013950969, 9611992, 1222315, 3012205930, 3004884150, 1000625496 +342 more
- FEI number
- 3011936113, 3004748290, 3001082453, 3002807692, 2245590, 3004201263, 3013111692, 4838, 3038715999, 3013551048, 3007518363, 3006592743, 3008517893, 3015775866, 3003110073, 3004883837, 3002806651, 3011587077, 3019252621, 3014270094, 3003267134, 3015160953, 3039641923, 3031462380, 3038549074, 3000215273, 2024024, 3008088588, 3014596751, 3027595870, 3003719498, 3011656326, 3002808636, 3013950969, 3012205930, 3004884150, 2921595, 3013465593, 3005674514, 3002807009 +342 more