Recall Z-0174-2015— Straumann USA, LLC

Name: FDA recall Z-0174-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-24

Class II · Terminated

Class II FDA medical device recall by Straumann USA, LLC, initiated 2014-09-24, terminated 2017-06-26. It names one FDA 510(k) clearance: K121131. Product: 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. Reason: Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC).

Recalling firm: Straumann USA, LLC
Classification: Class II
Status: Terminated
Initiated: 2014-09-24
Terminated: 2017-06-26
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K121131 — BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MMStraumann USA·cleared 2012-06-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.