Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Summary
The FDA issued a Class II for Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant by Straumann USA LLC. Reason: Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Eas.
Details
Source
Device Recall
External ID
Z-0512-2022
Action Date
2022-01-26
Status
Terminated
Category
device
Product Description
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Lot/Code Info: Lot GNV17 UDI: 7899878052722
Quantity Affected: 7 pieces
Reason for Recall
Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant
Distribution
US Nationwide Distribution in the states of FL, IL, OH
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-30
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 107 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-0512-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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