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U.S. Department of Health and Human Services

Class 2 Device Recall Neodent Implant System GM Line

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 Class 2 Device Recall Neodent Implant System GM Linesee related information
Date Initiated by FirmMay 01, 2025
Date PostedMay 28, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1863-2025
Recall Event ID 96806
510(K)NumberK163194 
Product Classification Implant, endosseous, root-form - Product Code DZE
ProductGM Helix Acqua Implant, Article Number: 140.985
Code Information Article Number: 140.985; UDI-DI: (01)7899878024569(11)220125(17)270124(10)JPZ75; Lot number: JPZ75;
FEI Number 1000121052
Recalling Firm/
Manufacturer		 Straumann USA LLC
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information ContactJennifer M. Jackson, MS, RAC
978-747-2560
Manufacturer Reason
for Recall		It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn May 1, 2025 URGENT FIELD SAFETY ACTION letters were sent to customers. Action to be taken: 1. If article 140.984 Lot JPZ21 or 109.985 Lot JPZ75 are still in your inventory, then stop use/distribution of the product immediately and quarantine/segregate physically. 2. If the product was used and no complications or problems were identified, of the patient did not present symptoms there is no need for any additional action with the patient. 3. If article 140.984 Lot JPZ21 or 109.985 Lot JPZ75 are still in your inventory, return it for a credit or replacement as indicated on the Customer Confirmation Form. 4. In the product is not found in your stock, indicate this on the enclosed Customer Confirmation Form. 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; 60 Minuteman Road, Andover, MA 01810. Transmission of the Field Safety Notice: This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. The FDA has been informed about this Field Safety Corrective Action. We apologize for any inconvenience that this may cause.
Quantity in Commerce207 units (54 US, 153 OUS)
DistributionWorldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, Il KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, WI and the countries of Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, UAE, United Kingdom, Vietnam.
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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