The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIE...

FDA Device Recall #Z-2458-2012 — Class II — July 27, 2012

Recall Summary

Recall Number Z-2458-2012
Classification Class II — Moderate risk
Date Initiated July 27, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Integra Limited
Location Plainsboro, NJ
Product Type Devices
Quantity 18 from Lot 093984 for Right Gel Pads

Product Description

The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The Gel Pads are supplied to users in labeled plastic bags, 1 per bag. Product Usage: The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. They are plastic gel filled devices that provide cushioning between the head and other metallic part of the MAYFIELD¿ system. The Left and Right Pads are mirror images.

Reason for Recall

An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were packaged as a Right Horseshoe Gel Pads and vice versa. None of the complaints resulted in a report of patient injuries or an increase in the time to complete the surgical procedure. A physician was consulted to assess patient risk and concluded that there is no potential harm to patients, onl

Distribution Pattern

Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DC, GA, IA, IL, IN, NC, and NY and the countries of: Canada and Belgium.

Lot / Code Information

The Lot No's for the affected Gel Pads are Lot 093984 of part number# 440C1011 for Right Gel Pads

Other Recalls from Integra Limited

Recall # Classification Product Date
Z-1338-2019 Class II Integra Flowable Wound Matrix Catalog No: FWD3... Mar 31, 2019
Z-1089-2019 Class II Integra bioBLOCK Resorbable subtaler Implant, 1... Mar 1, 2019
Z-1091-2019 Class II Integra bioBLOCK Resorbable subtaler Implant, 1... Mar 1, 2019
Z-1090-2019 Class II Integra bioBLOCK Resorbable subtaler Implant, 1... Mar 1, 2019
Z-0117-2014 Class II Brand Names: Integra¿ Camino 110-4 Intracranial... Sep 10, 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.