Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgica
Summary
The FDA issued a Class II for Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel by Straumann USA LLC. Reason: Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and c.
Details
Source
Device Recall
External ID
Z-2198-2021
Action Date
2021-08-11
Status
Terminated
Category
device
Product Description
Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
Lot/Code Info: Packaged lot number: EHG85 Lot Number engraved on part: CXV34
Quantity Affected: 130 pieces
Reason for Recall
Tip of the screwdriver does not have the correct configuration / profile therefore the screwdriver does not properly fit the opposing screw head and cannot pick up the screws, may result in injury
Distribution
US Nationwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-27
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 113 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-2198-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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