Z-0174-2015Class II

Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308

Name: Z-0174-2015 Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308
Creator: Straumann USA, LLC
Published: 2014-09-24
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2014-09-24 / Terminated / root cause: packaging

FDA source

Straumann USA, LLC began a recall of Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical... on 2014-09-24. FDA classified it as Class II and gives the reason as "Product transfer piece was fitted with a Narrow Connect (NC) instead of a 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-0174-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-24
Posted: 2014-11-06
Terminated: 2017-06-26
Recalling firm: Straumann USA, LLC
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
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Straumann USA sent a Field Corrective Action Notice letter dated September 24, 2014 and delivered via United Parcel Service. The letter identified the affected product, problem and actions to be taken. Straumann is requesting the return of unused implants. Returns and Customer Confirmation form is to be returned. Contact firm 781-747- 2514.
Quantity in commerce: 111 units
Distribution: US Nationwide Distribution
Product codes and lots: Lot number: GY256

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0174-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0174-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-12	2014-11-05

Product code DZE

K121131Class IIBl, 04.1 Mm Rc, Slactive 8Mm, Tizr and 10Mm, 12, 14MmStraumann USA / cleared 2012-06-06

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)