Z-2458-2012Class II

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

Name: Z-2458-2012 The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and MAYFIELD Swivel...
Creator: Integra Limited
Published: 2012-07-27
License: https://open.fda.gov/license/

Integra Lifesciences Sales LLC / initiated 2012-07-27 / Terminated / root cause: packaging

FDA source

Integra Limited began a recall of 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... on 2012-07-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2458-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-27
Posted: 2012-09-26
Terminated: 2013-02-20
Recalling firm: Integra Lifesciences Sales LLC
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.
Product code: FWZ Operating Room Accessories Table Tray
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
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: The Lot No's for the affected Gel Pads are Lot 093984 of part number# 440C1011 for Right Gel Pads

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2458-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2457-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-25
Z-2458-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-25

Product code FWZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)