Z-0174-2015 Class II Terminated
FDA device recall Z-0174-2015 was initiated by Straumann USA, LLC on September 24, 2014 and is designated Class II. Reason for recall: Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC) The recall status is terminated (terminated June 26, 2017). Affected quantity: 111 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 12, 2014
- Initiation Date
- September 24, 2014
- Termination Date
- June 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 111 units
Product Description
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)
Distribution Pattern
US Nationwide Distribution
Code Information
Lot number: GY256