Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SwishTapered Implant Recalled by Implant Direct Sybron Manufacturing, LLC Due to The extender product code (9037-03) that is packaged...

Date: December 12, 2016
Company: Implant Direct Sybron Manufacturing, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Implant Direct Sybron Manufacturing, LLC directly.

Affected Products

SwishTapered Implant

Quantity: 17

Why Was This 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.

Where Was This Sold?

This product was distributed to 6 states: CA, ME, NM, OH, OR, TX

Affected (6 states)Not affected

About Implant Direct Sybron Manufacturing, LLC

Implant Direct Sybron Manufacturing, LLC has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report