Straumann Bone Level Implant — Class II medical device recall Z-2534-2016
Terminated recall by Straumann Manufacturing, Inc., reported 2016-08-24, distributed nationwide. Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for opti
| Recall number | Z-2534-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Straumann Manufacturing, Inc., Andover, MA, United States |
| Recall initiated | 2016-07-14 |
| Classified | 2016-08-12 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2020-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 70 units |
| Lot numbers | LR810, LT122 |
Product
Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 021.4510
Reason for recall
Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
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-2534-2016. 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.