Home / Recalls / SpineFrontier, Inc. / Z-1664-2013

Z-1664-2013 Class II Terminated

Recalled by SpineFrontier, Inc. — Beverly, MA

Recall Details

Product Type
Devices
Report Date
July 10, 2013
Initiation Date
May 17, 2013
Termination Date
May 17, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12

Product Description

BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.

Reason for Recall

The S-LIFT Instrument Case contained a bracket with peeling nylon coating.

Distribution Pattern

USA Nationwide including the states of: FL, CO, Wash DC, VA, KS, TX, OH, TN, OK, CA, IL, MO, and MN.

Code Information

Lot/Serial Numbers: 7201.007 and 7201.007-1

Other recalls by SpineFrontier, Inc.

  • Z-1973-2019 Class II — A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Num (June 13, 2019)
  • 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-0573-2014 Class II — Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure (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-0575-2014 Class II — Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue (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-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-0553-2014 Class II — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 (November 20, 2013)