Recall Z-0117-2015— Straumann USA, LLC
Class II · Terminated
Class II FDA medical device recall by Straumann USA, LLC, initiated 2014-09-19, terminated 2015-03-13. It names one FDA 510(k) clearance: K140878. 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.. Reason: Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC).
- Recalling firm
- Straumann USA, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-19
- Terminated
- 2015-03-13
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.