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U.S. Department of Health and Human Services

Class 2 Device Recall GM Helix Implant

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 Class 2 Device Recall GM Helix Implantsee related information
Date Initiated by FirmAugust 12, 2026
Date PostedSeptember 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3173-2026
Recall Event ID 99707
510(K)NumberK163194 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductGM Helix Implant, REF: 109.984;
Code Information REF: 109.984; UDI: (01)7899878024552(11)251122(17)301121(10)VZPF4; Lot: VZPF4;
FEI Number 1000121052
Recalling Firm/
Manufacturer		 Straumann USA LLC
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information ContactTodd Shevlin
978-759-5442
Manufacturer Reason
for Recall		There is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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
Quantity in Commerce216
DistributionUS 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;
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DZE
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