Recall Z-0117-2015
Straumann USA, LLC · initiated September 19, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot number: GY030 Exp. 2019-04
Reason for recall
Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-0117-2015
- Initiated
- September 19, 2014
- Posted by FDA
- October 23, 2014
- Terminated
- March 13, 2015
- Product code
- DZE – Implant, Endosseous, Root-Form
- Quantity
- 6 units
- Distribution
- US Distribution in states of: FL and MA.
- Recalling firm
- Straumann USA, LLC, Andover, MA