The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2457-2012·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source explicitly states that no patient injuries were reported and a physician concluded there is no potential harm, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Integra Limited is recalling 11 units of MAYFIELD Horseshoe Gel Pads from Lot 0938990. These medical devices are used in conjunction with MAYFIELD Base Units and Swivel Adaptors to provide cranial stability during neurosurgical procedures. The recall was initiated after an investigation of customer complaints revealed that for two product lots, Left Horseshoe Gel Pads were packaged as Right Horseshoe Gel Pads, and vice versa.

The affected products were distributed worldwide, including nationwide in the United States (specifically AZ, CA, CO, DC, GA, IA, IL, IN, NC, and NY) and in Canada and Belgium. The source text states that none of the complaints resulted in a report of patient injuries or an increase in the time to complete the surgical procedure. A physician consulted to assess patient risk concluded that there is no potential harm to patients.

Healthcare facilities should stop using the affected gel pads and contact Integra Limited for instructions on return or replacement. This recall is classified as Class II by the FDA.

The recalled product

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…
Manufacturer
Integra Limited
Category
Medical Device — Neurosurgical Equipment
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Integra Limited under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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