S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, re...

FDA Device Recall #Z-0274-2014 — Class II — August 28, 2013

Recall Summary

Recall Number Z-0274-2014
Classification Class II — Moderate risk
Date Initiated August 28, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm SpineFrontier, Inc.
Location Beverly, MA
Product Type Devices
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

Lot / 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 from SpineFrontier, Inc.

Recall # Classification Product Date
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Z-1479-2015 Class II SpineFrontier MISquito Percutaneous Pedicle S... Mar 5, 2015
Z-0977-2015 Class II lnline Persuader- PedFuse Pedicle Screw System;... Dec 19, 2014
Z-0576-2014 Class II Indus Invue Screws: IM71013-XX: Indus Screw04.0... Nov 20, 2013
Z-0554-2014 Class II PedFuse Reset Screw Inserters; PedFuse Screw In... Nov 20, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.