Home / Recalls / SpineFrontier, Inc. / Z-0554-2014

Z-0554-2014 Class II Terminated

Recalled by SpineFrontier, Inc. — Beverly, MA

Recall Details

Product Type
Devices
Report Date
January 1, 2014
Initiation Date
November 20, 2013
Termination Date
June 26, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25

Product Description

PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-80111 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.

Reason for Recall

Screw inserters may not mate properly with hex interface of the screws.

Distribution Pattern

US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. .

Code Information

VM 13194-34457

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-0553-2014 Class II — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 (November 20, 2013)
  • Z-0576-2014 Class II — Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secur (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-0573-2014 Class II — Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure (November 20, 2013)
  • Z-0544-2014 Class II — PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw impla (October 18, 2013)