FDA Recall
Terminated
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.
Recall: Z-0117-2015
·
Initiated September 19, 2014
Recall
- Recall Number
- Z-0117-2015
- Event Number
- 69379
- Firm
- Straumann USA, LLC
- FEI Number
- 1000121052
- Product Code
- DZE
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- September 19, 2014
- Posted
- October 23, 2014
- Terminated
- March 13, 2015
- Address
- 60 Minuteman Rd, Andover, MA, 01810-1008
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
Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
Action
Strauman notified consignees of this Field Corrective Action by letter dated September 19, 2014 and delivered via hand by Straumann Representative. Accounts are requested to return inventory. Contact (978) 747-2514 for assistance.
Distribution
US Distribution in states of: FL and MA.
Quantity
6 units