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.
This recall has been terminated (originally issued October 23, 2014).
- Company
- Straumann Usa Llc
- Recall Initiated
- September 19, 2014
- Posted
- October 23, 2014
- Terminated
- March 13, 2015
- Recall Number
- Z-0117-2015
- Quantity
- 6 units
- Firm Location
- Andover, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
Distribution
US Distribution in states of: FL and MA.
Lot / Code Info
Lot number: GY030 Exp. 2019-04
Root 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.
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