GM Helix Acqua Implant recall
GM Helix Acqua Implant, Article Number: 140.985
Why was GM Helix Acqua Implant recalled?
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Article Number: 140.985; UDI-DI: (01)7899878024569(11)220125(17)270124(10)JPZ75; Lot number: JPZ75;
- Product
- GM Helix Acqua Implant, Article Number: 140.985
- Recalling firm
- Straumann USA LLC
- Quantity
- 207 units (54 US, 153 OUS)
- Distribution
- 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.
- Recall date
- June 4, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)