Straumann USA, LLC: Medical Device Recall in 2014 - (Recall #: Z-0117-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 19, 2014

Date Posted: October 29, 2014

Recall Number: Z-0117-2015

Event ID: 69379

Reason for Recall:

Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)

Status: Terminated

Product Quantity: 6 units

Code Information:

Lot number: GY030 Exp. 2019-04

Distribution Pattern:

US Distribution in states of: FL and MA.

Voluntary or Mandated:

Voluntary: Firm initiated