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Terminated

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

FDA Recall Z-0174-2015 · Posted 2014-11-06

Recalling FirmStraumann USA, LLC
Recall StatusTerminated
Product CodeDZE
Date Initiated2014-09-24
Date Terminated2017-06-26
Product Quantity111 units

Reason for Recall

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

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121131BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MMStraumann USA · 2012-06-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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