Implant Direct Sybron Manufacturing, LLC recalls SwishTapered Implant

Recall date

December 12, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1112-2017

FDA classification

Class II

Brand / firm

Implant Direct Sybron Manufacturing, LLC

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SwishTapered Implant