Devices

Device Recall MAYFIELD Horseshoe Gel Pads Right Gel Pad

Model / Serial
The Lot No's for the affected Gel Pads are Lot 093984 of part number# 440C1011 for Right Gel Pads
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
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 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.
Manufacturer
Integra Limited
1 Event
- Recall of Device Recall MAYFIELD Horseshoe Gel Pads Right Gel Pad

Manufacturer

Integra Limited

Manufacturer Address
Integra Limited, 311 Enterprise Dr, Plainsboro NJ 08536-3344
Source
USFDA

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