Device 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
Z-0174-2015
Product summary
- Event
- Event 69454
- Status
- Terminated
- Classification
- Class II
- Quantity
- 111 units
- Official record key
device-enforcement:Z-0174-2015
Official wording
Reason: Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
Code information: Lot number: GY256
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)