Implex Hedrocel Replacement Cup Insert Model Numbers 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY - 02-247-Xxyyy

• • Terminated Z-1954-2016 FDA Class II ·initiated 15 Apr 2016

  Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.

510(k) Number

K983128 ↗

FDA Product Code

JDI

Models / Variants

Numbers 02-246-Xxyyy

02-247-Xxyyy

02-248-Xxyyy

Device Class

Class II

Regulation

21 CFR Part 888.3350

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• The Trabecular Metal Technology Acetabular Augment System, Models 4893-Xx-Yy (Zimmer), 02-212-05XX1 ( Implex)

  Class II

  FDA 510(k) K012507 Active Cleared 30 Aug 2001

• Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1

  Class II

  FDA 510(k) K051196 Active Cleared 17 Jun 2005

• Hydrocel Vertebral Body Replacement, Model 06-172-00XX1

  Class II

  FDA 510(k) K022563 Active Cleared 30 Aug 2002

• Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder Solution

  Class II

  FDA 510(k) K031449 Active Cleared 23 Sep 2003

• Implex Continuum Porous Patellar

  Class II

  FDA 510(k) K971789 Active Cleared 24 Jul 1997

• Implex Hep Acetabular Revision Cup, Cemented or Cementless Model A-240 System

  Class II

  FDA 510(k) K980486 Active Cleared 14 Apr 1998

See all devices from Implex Corp. →

• What is the Implex Hedrocel Replacement Cup Insert used for?

  The Implex Hedrocel Replacement Cup Insert is an orthopedic implant device designed for use in hip replacement surgeries. It serves as a cup insert component in the hip replacement system, providing a bearing surface for the prosthetic hip joint.

• How is the Implex Hedrocel Replacement Cup Insert supplied?

  The device is supplied in various model numbers including 02-246-XXYYY, 02-247-XXYYY, and 02-248-XXYYY. It is intended for single-use in surgical procedures and comes in different sizes to accommodate various patient anatomies.

• What is the regulatory status of the Implex Hedrocel Replacement Cup Insert?

  The product is regulated under FDA 510(k) clearance with the product code JDI, indicating its classification as a total hip replacement system component. It received FDA clearance on December 3, 1998, with K number K983128.

• Is the Implex Hedrocel Replacement Cup Insert reusable?

  No, the Implex Hedrocel Replacement Cup Insert is intended for single-use only in surgical procedures. After use, it should not be reused on another patient as this could compromise sterility and device performance.