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Terminated

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 Recall Z-0117-2015 · Posted 2014-10-23

Recalling FirmStraumann USA, LLC
Recall StatusTerminated
Product CodeDZE
Date Initiated2014-09-19
Date Terminated2015-03-13
Product Quantity6 units

Reason for Recall

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

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

US Distribution in states of: FL and MA.

Official Source

View FDA Recall →

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

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