Medpor Craniofacial Implants with Embedded Titanium Mesh

• • Terminated Z-0715-2022 FDA Class II ·initiated 29 Dec 2021

  Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.

• • Terminated Z-1093-2015 FDA Class II ·initiated 17 Dec 2014 ·on shared 510(k) K040364

  Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Titan Max OFW - MTB - Left. The appropriate articles were actually included in the shipment. However, the products had an incorrect barrier location.

• • Terminated Z-0922-2012 FDA Unclassified (pre-2012) ·initiated 16 Dec 2011

  The template that is packaged with this implant was not packaged according to specification. The template was packaged in a single pouch instead of a double pouch.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K040364 ↗

FDA Product Code

FTM

Device Class

Class II

Regulation

21 CFR Part 878.3300

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Medpor Surgical Granule Implants

  Class II

  FDA 510(k) K982040 Active Cleared 8 Sep 1998

• Porex Nostril Retainers

  Class I

  FDA 510(k) K981374 Active Cleared 2 Jul 1998

• Medpor Quad Motility Implant

  Class II

  FDA 510(k) K010902 Active Cleared 19 Jun 2001

• Medpor Surgical Implant Material

  Class II

  FDA 510(k) K943275 Active Cleared 2 Sep 1994

• Medpor Plus Orbital Volume Replacement Impant

  Class II

  FDA 510(k) K021357 Active Cleared 5 Aug 2002

• Porex Electrosurgery Needle

  Class II

  FDA 510(k) K052297 Active Cleared 28 Mar 2006

See all devices from Porex Surgical, Inc. →