Summary
The FDA issued a Class II for GM Helix Acqua Implant, Article Number: 140.984 by Straumann USA LLC. Reason: It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead..
Details
Source
Device Recall
External ID
Z-1862-2025
Action Date
2025-06-04
Status
Ongoing
Category
device
Product Description
GM Helix Acqua Implant, Article Number: 140.984
Lot/Code Info: Article Number: 140.984; UDI-DI: (01)7899878025290(11)220122(17)260121(10)JPZ21; Lot number: JPZ21;
Quantity Affected: 300 units (125 US, 175 OUS)
Reason for Recall
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-01
Company
Andover, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 185 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Straumann USA LLC has 17 FDA actions in our database, including 15 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Straumann USA LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Straumann USA LLC have FDA actions?
Straumann USA LLC has 17 FDA actions in our database, including 15 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1862-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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