GM Helix Acqua Implant, Article Number: 140.984
Recall
- Recall Number
- Z-1862-2025
- Event Number
- 96806
- Firm
- Straumann USA LLC
- FEI Number
- 1000121052
- Product Code
- DZE
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- May 1, 2025
- Posted
- May 28, 2025
- Address
- 60 Minuteman Rd, Andover, MA, 01810-1008
Description
GM Helix Acqua Implant, Article Number: 140.984
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
On 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.
Worldwide - 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.
300 units (125 US, 175 OUS)