Toggleloc and Juggerloc Implants/Instruments/Kits

• • Terminated Z-0809-2022 FDA Class II ·initiated 14 Feb 2022

  Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.

• • Terminated Z-1363-2015 FDA Class II ·initiated 26 Feb 2015

  The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed.

510(k) Number

K141263 ↗

FDA Product Code

JDR

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Comprehensive® Convertible Glenoid - Vivacit-E Liner

  Class II

  FDA 510(k) K211729 Active Cleared 4 Nov 2021

• Modular Hybrid Glenoid

  Class II

  FDA 510(k) K060694 Active Cleared 11 Dec 2006

• Altra Press-Fit Hip System

  Class III

  FDA 510(k) K063002 Active Cleared 31 Oct 2006

• Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument Kits

  Class II

  FDA 510(k) K141219 Active Cleared 18 Jul 2014

• Biomet Headless Compression and Twist-off Screws

  Class II

  FDA 510(k) K142658 Active Cleared 13 Nov 2014

• ExpressBraid Graft Manipulation

  Class II

  FDA 510(k) K152868 Active Cleared 8 Feb 2016

See all devices from Biomet Manufacturing Corp →