FDA Device recall Z-1561-2025
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel
- FDA Device
- Class II
- ongoing
- Published 2025-04-23
On 2025-04-23 the FDA classified a Class II recall of TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel by Straumann Usa, citing the devices are missing the laser marked depth markings.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1561-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-08 |
| Published | 2025-04-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Straumann Usa |
| Distribution | US |
Product
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Reason
The devices are missing the laser marked depth markings.
Identifiers
| code_info | REF: 037.3002; UDI-DI: 07630031750587; Packaging Lot number: LGMZ8, GLKJ9; Lot number engraved on part: HTXT5. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1561-2025%22
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