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SwishTapered Implant

FDA Recall #Z-1112-2017 — Class II — December 12, 2016

Recall #Z-1112-2017 Date: December 12, 2016 Classification: Class II Status: Terminated

Product Description

SwishTapered Implant

Reason for Recall

The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.

Recalling Firm

Implant Direct Sybron Manufacturing, LLC — Westlake Village, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

17

Distribution

U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.

Code Information

933308 Lot # 73241

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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