TLX/TLC SP Guided Implant Driver — Class II medical device recall Z-1561-2025
Ongoing recall by Straumann USA LLC, reported 2025-04-23, distributed nationwide. The devices are missing the laser marked depth markings.
| Recall number | Z-1561-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Straumann USA LLC, Andover, MA, United States |
| Recall initiated | 2025-03-08 |
| Classified | 2025-04-14 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, DE, FI, FR, GB, IL, IS, IT, LV, MT, RO, UA |
| Quantity | 45 units |
| UPC / GTIN / UDI-DI | 07630031750587 |
| Lot numbers | GLKJ9, LGMZ8 |
| Model numbers | 037.3002, HTXT5 |
Product
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Reason for recall
The devices are missing the laser marked depth markings.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1561-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.