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Terminated

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.

FDA Recall Z-2457-2012 · Posted 2012-09-26

Recalling FirmIntegra Limited
Recall StatusTerminated
Product CodeFWZ
Date Initiated2012-07-27
Date Terminated2013-02-20
Product Quantity11 from Lot 0938990

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

Firm Action

Integra Lifesciences sent an "URGENTURGENT: VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" letter dated July 27, 2012 to all affected customers. The letter identifies the affected products, problem and actions to be taken by the customers. Customers were instructed to check their inventory for affected products and quarantine them for shipment back to Integra. Customers were asked to complete the Recall Acknowledgement and Return Forms ASAP whether or not they intended on returning any recalled product. Contact Integra Customer Service at 1-877-444-1114, Option 3 for Technical Support.

Root Cause

Packaging process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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