Device product
Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 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.
Z-0117-2015
Product summary
- Event
- Event 69379
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-0117-2015
Official wording
Reason: Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
Code information: Lot number: GY030 Exp. 2019-04
Distribution pattern: US Distribution in states of: FL and MA.
Derived failure modes
-
Unknown
Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)