The Recall Desk

FDA (Devices) recall action 62711

Integra Limited recalled 2 products on 2012-10-03

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2012-10-03
Critical
0
Units
—

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2012-10-03

    Integra Limited Recalls Mispackaged MAYFIELD Horseshoe Gel Pads

    Integra Limited is recalling 11 MAYFIELD Horseshoe Gel Pads from Lot 0938990 because left and right pads were incorrectly packaged. No patient injuries were reported.

    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 G
    Category
    Distribution
    10 states
  • ModerateFDA (Devices)··2012-10-03

    Integra Limited Recalls Mayfield Horseshoe Gel Pads Due to Packaging Error

    Integra Limited is recalling Mayfield Horseshoe Gel Pads because left and right pads were incorrectly packaged. No patient injuries or surgical delays were reported.

    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 G
    Category
    Distribution
    10 states