—#130365

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.

FDA product code: DZE — Implant, Endosseous, Root-Form
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K140878
Affected lot / code info: Lot number: GY030 Exp. 2019-04

Why it was recalled

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

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Straumann USA, LLC
Address: 60 Minuteman Rd, Andover, Massachusetts 01810-1008

Distribution

Distribution pattern: US Distribution in states of: FL and MA.

Timeline

Recall initiated: 2014-09-19
Posted by FDA: 2014-10-23
Terminated: 2015-03-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130365. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.