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U.S. Department of Health and Human Services

Class 2 Device Recall Straumann

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  Class 2 Device Recall Straumann see related information
Date Initiated by Firm May 27, 2021
Create Date August 03, 2021
Recall Status1 Terminated 3 on March 21, 2023
Recall Number Z-2198-2021
Recall Event ID 88282
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
Product Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel
Article Number: 046.401. dental surgical instrument.
Code Information Packaged lot number: EHG85 Lot Number engraved on part: CXV34
Recalling Firm/
Manufacturer		 Straumann USA LLC
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information Contact SAME
978-747-2560
Manufacturer 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
FDA Determined
Cause 2		 Under Investigation by firm
Action Straumann USA issued Urgent Medical Device Recall letter on 5/27/21 via 2nd day air via UPS with email confirmation of request. Letter states reason for recall , health risk and action to take: Action to be taken: 1. If the article 046.401 (lot EHG85) is still in your inventory, then stop use / distribution of the product immediately and quarantine / segregate physically. 2. If the article 046.401 (lot EHG85) is still in your inventory, return it to the attention of Meaghan Atwell for credit or replacement as indicated on the Customer Confirmation Form. 3. Complete and return the enclosed Customer Confirmation Form to FSCA ER21-0077, Straumann USA, LLC; 60 Minuteman Road, Andover, MA 01810 or email reg_complaint@straumann.com. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred.
Quantity in Commerce 130 pieces
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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