TLX/TLC SP Guided Implant Driver recall
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Why was TLX/TLC SP Guided Implant Driver recalled?
The devices are missing the laser marked depth markings.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF: 037.3002; UDI-DI: 07630031750587; Packaging Lot number: LGMZ8, GLKJ9; Lot number engraved on part: HTXT5.
- Product
- TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
- Recalling firm
- Straumann USA LLC
- Quantity
- 45 units
- Distribution
- Worldwide - 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.
- Recall date
- April 23, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)