Z-0117-2015Class II

Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021 .5308...

Name: Z-0117-2015 Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021 .5308...
Creator: Straumann USA, LLC
Published: 2014-09-19
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2014-09-19 / Terminated / root cause: packaging

FDA source

Straumann USA, LLC began a recall of 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... on 2014-09-19. FDA classified it as Class II and gives the reason as "Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0117-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-19
Posted: 2014-10-23
Terminated: 2015-03-13
Recalling firm: Straumann USA, LLC
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.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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.
Quantity in commerce: 6 units
Distribution: US Distribution in states of: FL and MA.
Product codes and lots: Lot number: GY030 Exp. 2019-04

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0117-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0117-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-23

Product code DZE

K140878Class IIStraumann Bone Level Tapered ImplantStraumann USA, LLC / cleared 2014-08-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)