Recall Z-2458-2012— Integra Limited

Class II FDA medical device recall by Integra Limited, initiated 2012-07-27, terminated 2013-02-20. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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.

Recalling firm

Integra Limited

Classification

Class II

Status

Terminated

Initiated

2012-07-27

Terminated

2013-02-20

Firm location

Plainsboro, NJ, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.