GM Helix Acqua Implant dental implant size misidentification recall
Straumann USA LLC is recalling the GM Helix Acqua Implant (Article Number 140.985) because some packages labeled as 11.5 mm implants may contain 13 mm implants instead.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a medical device with a risk of harm (incorrect implant size could lead to improper surgical placement and patient injury). The source text does not report any actual illnesses or injuries, but the potential for harm from implanting an incorrectly sized dental implant during surgery warrants a High severity classification.
Plain-English summary
Straumann USA LLC is recalling the GM Helix Acqua Implant, Article Number 140.985, due to a labeling and contents mismatch. Some packages labeled as 11.5 mm implants may contain 13 mm implants instead.
A total of 207 units have been distributed: 54 units in the United States and 153 units internationally. In the U.S., affected units were distributed to AZ, CA, CO, FL, GA, IL, KS, LA, MA, MD, MI, NE, NH, NJ, NY, OH, OK, RI, SC, TN, TX, UT, and WI. International distribution includes Australia, Croatia, France, Hungary, India, Italy, Lebanon, Lithuania, New Zealand, Portugal, Qatar, Serbia, Spain, Tunisia, UAE, United Kingdom, and Vietnam.
The recall applies to Lot JPZ75 with the following identifiers: UDI-DI (01)7899878024569(11)220125(17)270124(10)JPZ75. If you have received this product, verify the actual implant size against the package label before use. Contact Straumann USA LLC if you have questions or suspect you have received an affected unit.
The recalled product
- Product
- GM Helix Acqua Implant, Article Number: 140.985
- Manufacturer
- Straumann USA LLC
- Category
- Medical Device — Dental Implant
- Hazard
- size-mismatch
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Article Number: 140.985
- UDI-DI: (01)7899878024569(11)220125(17)270124(10)JPZ75
- Lot number: JPZ75
Distribution
Distributed nationwide across the United States.
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