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U.S. Department of Health and Human Services

Class 2 Device Recall MAYFIELD Horseshoe Gel Pads Right Gel Pad

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  Class 2 Device Recall MAYFIELD Horseshoe Gel Pads Right Gel Pad see related information
Date Initiated by Firm July 27, 2012
Date Posted September 26, 2012
Recall Status1 Terminated 3 on February 20, 2013
Recall Number Z-2458-2012
Recall Event ID 62711
Product Classification Accessories, operating-room, table (kit) - Product Code FWZ
Product 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.
Code Information The Lot No's for the affected Gel Pads are Lot 093984 of part number# 440C1011 for Right Gel Pads
Recalling Firm/
Manufacturer
Integra Limited
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Michael Molloy
609-275-0500
Manufacturer 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
FDA Determined
Cause 2
Packaging process control
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.
Quantity in Commerce 18 from Lot 093984 for Right Gel Pads
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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