Home / Recalls / SpineFrontier, Inc. / Z-1973-2019

Z-1973-2019 Class II Terminated

Recalled by SpineFrontier, Inc. — Malden, MA

Recall Details

Product Type
Devices
Report Date
July 24, 2019
Initiation Date
June 13, 2019
Termination Date
May 11, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6

Product Description

A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)

Reason for Recall

There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.

Distribution Pattern

The products were distributed to the following US states: AZ, MD, MO, and FL.

Code Information

Lot EC20

Other recalls by SpineFrontier, Inc.

  • Z-1479-2015 Class II — SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; P (March 5, 2015)
  • Z-0977-2015 Class II — lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164 (December 19, 2014)
  • Z-0574-2014 Class II — Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secu (November 20, 2013)
  • Z-0576-2014 Class II — Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secur (November 20, 2013)
  • Z-0573-2014 Class II — Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure (November 20, 2013)
  • Z-0575-2014 Class II — Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue (November 20, 2013)
  • Z-0553-2014 Class II — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 (November 20, 2013)
  • Z-0554-2014 Class II — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-8011 (November 20, 2013)
  • Z-0555-2014 Class II — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 08-9 REset Part# 11-80113 (November 20, 2013)
  • Z-0544-2014 Class II — PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw impla (October 18, 2013)