Straumann Bone Level Implant 04 — Class II medical device recall Z-0174-2015
Terminated recall by Straumann USA, LLC, reported 2014-11-12, distributed nationwide. Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
| Recall number | Z-0174-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Straumann USA, LLC, Andover, MA, United States |
| Recall initiated | 2014-09-24 |
| Classified | 2014-11-05 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2017-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 111 units |
| Lot numbers | GY256 |
Product
Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used
Reason for recall
Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
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-0174-2015. 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.