Z-0117-2015 Class II Terminated
FDA device recall Z-0117-2015 was initiated by Straumann USA, LLC on September 19, 2014 and is designated Class II. Reason for recall: Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC) The recall status is terminated (terminated March 13, 2015). Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 29, 2014
- Initiation Date
- September 19, 2014
- Termination Date
- March 13, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
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.
Reason for Recall
Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
Distribution Pattern
US Distribution in states of: FL and MA.
Code Information
Lot number: GY030 Exp. 2019-04