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U.S. Department of Health and Human Services

Class 2 Device Recall TLX/TLC Guided Implant Driver for ratchet

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 Class 2 Device Recall TLX/TLC Guided Implant Driver for ratchetsee related information
Date Initiated by FirmMarch 08, 2025
Date PostedApril 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1561-2025
Recall Event ID 96516
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
ProductTLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Code Information REF: 037.3002; UDI-DI: 07630031750587; Packaging Lot number: LGMZ8, GLKJ9; Lot number engraved on part: HTXT5.
FEI Number 1000121052
Recalling Firm/
Manufacturer		 Straumann USA LLC
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information ContactJennifer M. Jackson, MS, RAC
978-747-2509
Manufacturer Reason
for Recall		The devices are missing the laser marked depth markings.
FDA Determined
Cause 2		Process control
ActionOn March 8, 2024 URGENT FIELD SAFETY ACTION letters were sent to customers. Action to be taken: 1. If Article 037.3002 from Lots LGMZ8 and GLKJ9 is still in your inventory, then stop use/distribution of the product immediately and quarantine/segregate physically. 2. If Article 037.3002 from Lots LGMZ8 and GLKJ9 is still in your inventory, return it for a replacement as indicated on the Customer Confirmation Form 3. In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided to: Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 Transmission of the Field Safety Notice 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. The FDA has been informed about this Field Safety Corrective Action We apologize for any inconvenience that this may cause.
Quantity in Commerce45 units
DistributionWorldwide - US Nationwide distribution in the states of CA, IN, ME, MN and the countries of Belgium, Finland, France, Germany, Iceland, Israel, Italy, Latvia, Malta, Romania, Switzerland, Ukraine, United Kingdom.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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