Home / Recalls / SpineFrontier, Inc. / Z-0274-2014

Z-0274-2014 Class II Terminated

Recalled by SpineFrontier, Inc. — Beverly, MA

Recall Details

Product Type
Devices
Report Date
November 20, 2013
Initiation Date
August 28, 2013
Termination Date
September 13, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
67

Product Description

S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field.

Reason for Recall

Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades.

Distribution Pattern

Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT

Code Information

Part Number/Lot Number: 11-50109 43092R; 11-50109 46415; 11-50109 CT12H013; 11 -50109-1 46415-1; 11-50110 43089; 11-50110 43089R; 11-50110 46416; 11-50110-1 46416-1

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-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-0554-2014 Class II — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REspond Part# 11-8011 (November 20, 2013)
  • Z-0576-2014 Class II — Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secur (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-0553-2014 Class II — PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 (November 20, 2013)