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Recall Observatory FDA recall evidence

Device 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.

Z-2457-2012

July 27, 2012

Class II

Product summary

Firm
Integra Limited
Event
Event 62711
Status
Terminated
Classification
Class II
Quantity
11 from Lot 0938990
Official record key
device-enforcement:Z-2457-2012

Official wording

Reason: 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

Code information: The Lot No's for the affected Gel Pads are Lot 093990 of part number #440C1012 for Left Gel Pads

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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