FDA Medical devices recall ·
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel recall
- Recall number
- Z-1561-2025
- Date
- (initiated March 8, 2025)
- Company / brand
- Straumann USA LLC
60 Minuteman Rd, Andover, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 45 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Why was it recalled?
The devices are missing the laser marked depth markings.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF: 037.3002; UDI-DI: 07630031750587; Packaging Lot number: LGMZ8, GLKJ9; Lot number engraved on part: HTXT5.
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.
States: California Indiana Maine Minnesota
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1561-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.