Straumann USA, LLC: Medical Device Recall in 2014 - (Recall #: Z-0174-2015)

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 Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: 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. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used

Product Classification:

Class II

Date Initiated: September 24, 2014

Date Posted: November 12, 2014

Recall Number: Z-0174-2015

Event ID: 69454

Reason for Recall:

Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)

Status: Terminated

Product Quantity: 111 units

Code Information:

Lot number: GY256

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated